THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Registration Details

Registration Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Registration Number: 1523845
FEI Number: 1523845
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 401 MILLCREEK RD.
City: MARIETTA
State: OH
ZIP: 45750
Country: US

Regulatory Submissions

510(k) Number: K001524

Owner / Operator

Firm Name: THERMO FISHER SCIENTIFIC INC.
Operator Number: 2182773
Address: 168 Third Avenue, --
City: Waltham
State: MA
Postal Code: 02451
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Freezer	JRM	Class 1	Clinical Chemistry	No	1978-09-11
Bath, Incubators/Water, All	JTQ	Class 1	Microbiology	No	1999-01-27
Anaerobic Box Glove	JTM	Class 1	Microbiology	No	2004-06-18
Refrigerator, Freezer, Blood Storage	KSE	Class 2	Hematology	No	1992-11-04
Accessory, Assisted Reproduction	MQG	Class 2	Obstetrics/Gynecology	No	2008-01-16
Shaker/Stirrer	JRQ	Class 1	Clinical Chemistry	No	1994-05-10
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	Class 1	Clinical Chemistry	No	2004-09-22

Proprietary Names

Fisher Scientific ISOTemp ULT 1920CD CHST 230/60 (I920CD) Thermo Scientific Chest Freezer ULT TSC1390V CHEST 230/50 (TSC1390V) Thermo Scientific Forma Cryopreservation, General Purpose (7453) Thermo Scientific Forma ULT 7240D UPRIGHT 230/60 (7240D) Thermo Scientific Forma ULT 817CD 17 CHEST 230/60 (817CD) Thermo Scientific HeraFreeze ULT HFU600BV UPRT 230/50 (HFU600BV) Thermo Scientific Revco ULT390-10-V CHST 230/50 (ULT390-10-V) Thermo Scientific Upright Freezer ULT TSD40240V UPRT 230/50 (TSD40240V) Thermo Scientific Jewett Plasma Freezer JPL430A, JPL430D, JPL430V, JPL430W Thermo Scientific Chest Freezer ULT TSC390A CHEST 120/60 (TSC390A) Thermo Scientific Forma Laboratory Refrigerators and Freezers (910) Thermo Scientific HeraFreeze ULT HFC1790TD CHST 230/60 (HFC1790TD) Thermo Scientific HeraFreeze ULT HFU400BA UPRT 120/60 (HFU400BA) Thermo Scientific Revco ULT EXF40086V UPRT 230/50 (EXF40086V) Thermo Scientific Chest Freezer ULT TSC1350V CHEST 230/50 (TSC1350V) Thermo Scientific Chest Freezer ULT TSC2090D CHEST 230/60 (TSC2090D) Thermo Scientific Forma Cryopreservation, General Purpose (7450) Thermo Scientific Forma Laboratory Refrigerators and Freezers (906) Thermo Scientific HeraFreeze ULT HFC1750TA CHST 120/60 (HFC1750TA) Thermo Scientific ISOTemp ULT IU2886V UPRT 230/50 (IU2886V) Thermo Scientific Revco ULT EXF32086D UPRT 230/60 (EXF32086D) Thermo Scientific TSE Series ULT TSE600V UPRT 230/50 (TSE600V) Fisher Scientific ISOTemp ULT I903CV CHST 230/50 (I903CV) Thermo Scientific Forma ULT 703CA CHEST 120/60 (703CA) Thermo Scientific Forma ULT 7320A UPRIGHT 120/60 (7320A) Thermo Scientific Revco ULT1790-10-A CHST 120/60 (ULT1790-10-A) Thermo Scientific TSE Series ULT TSE240D UPRT 230/60 (TSE240D) Thermo Scientific Chest Freezer ULT TSC1350D CHEST 230/60 (TSC1350D) Thermo Scientific Chest Freezer ULT TSC2090A CHEST 120/60 (TSC2090A) Thermo Scientific Forma Cryopreservation, General Purpose (7407) Thermo Scientific Forma Laboratory Refrigerators and Freezers (905) Thermo Scientific Forma ULT 813CA 12 CHEST 120/60 (813CA) Thermo Scientific HeraFreeze ULT HFC1390TV CHST 230/50 (HFC1390TV) Thermo Scientific ISOTemp ULT IU2886D UPRT 230/60 (IU2886D) Thermo Scientific TSE Series ULT TSE600D UPRT 230/60 (TSE600D) Thermo Scientific Jewett Plasma Freezer JPL1230A, JPL1230V, JPL1230W Fisher Scientific ISOTemp ULT I920CA CHST 120/60 (I920CA) Thermo Scientific Forma Cryopreservation, General Purpose (7404) Thermo Scientific Forma ULT 7400V UPRIGHT 230/50 (7400V) Thermo Scientific HeraFreeze ULT HFC1350TV CHST 230/50 (HFC1350TV) Thermo Scientific ISOTemp ULT IU2386A UPRT 120/60 (IU2386A) Thermo Scientific TSE Series ULT TSE400A UPRT 120/60 (TSE400A) Thermo Scientific Forma Cryopreservation, General Purpose (7400) Thermo Scientific Forma Laboratory Refrigerators and Freezers (957) Thermo Scientific Forma ULT 713CV CHEST 230/50 (713CV) Thermo Scientific HeraFreeze ULT HFU400BV UPRT 230/50 (HFU400BV) Thermo Scientific Revco ULT EXF60086V UPRT 230/50 (EXF60086V) Thermo Scientific Revco ULT2050-10-D -40 230/60 (ULT2050-10-D) Fisher Scientific ISOTemp ULT I917CA CHST 120/60 (I917CA) Thermo Scientific Forma Cryopreservation, General Purpose (7402) Thermo Scientific Forma ULT 7400A UPRIGHT 120/60 (7400A) Thermo Scientific ISOTemp ULT IU1786D UPRT 230/60 (IU1786D) Thermo Scientific Revco ULT2050-10-A -40 120/60 (ULT2050-10-A) Thermo Scientific TSE Series ULT TSE320D UPRT 230/60 (TSE320D) Thermo Scientific Chest Freezer ULT TSC1790A CHEST 120/60 (TSC1790A) Thermo Scientific Forma Cryopreservation, General Purpose (7473) Thermo Scientific Forma ULT 820CV CHEST 230/50 (820CV) Thermo Scientific HeraFreeze ULT HFC2090TV CHST 230/50 (HFC2090TV) Thermo Scientific ISOTemp ULT IU1786A UPRT 120/60 (IU1786A) Thermo Scientific Revco ULT DXF40040A UPRT 120/60 (DXF40040A) Thermo Scientific Upright Freezer ULT TSD40400A UPRT 120/60 (TSD40400A) Fisher Scientific ISOTemp ULT I920CV CHST 230/50 (I920CV) Thermo Scientific Chest Freezer ULT TSC2050D CHEST 230/60 (TSC2050D) Thermo Scientific Forma Cryopreservation, General Purpose (7405) Thermo Scientific Forma ULT 803CA 03 CHEST 115/60 (803CA) Thermo Scientific HeraFreeze ULT HFC1390TA CHST 120/60 (HFC1390TA) Thermo Scientific ISOTemp ULT IU2386D UPRT 230/60 (IU2386D) Thermo Scientific TSE Series ULT TSE400D UPRT 230/60 (TSE400D) Thermo Scientific Jewett Plasma Freezer CTF306-2A Thermo Scientific Chest Freezer ULT TSC350V CHEST 230/50 (TSC350V) Thermo Scientific Forma Laboratory Refrigerators and Freezers (909) Thermo Scientific HeraFreeze ULT HFC1790TA CHST 120/60 (HFC1790TA) Thermo Scientific HeraFreeze ULT HFU320BV UPRT 230/50 (HFU320BV) Thermo Scientific Revco ULT DXF24040V UPRT 230/50 (DXF24040V) Thermo Scientific Revco ULT EXF40086D UPRT 230/60 (EXF40086D) Thermo Scientific Forma Plasma Freezer FFPF2330A, FFPF2330D, FFPF2330V, FFPF2330W Thermo Scientific Forma Plasma Freezer FFPF430A, FFPF430V, FFPF430W Thermo Scientific Chest Freezer ULT TSC1790V CHEST 230/50 (TSC1790V) Thermo Scientific Forma Cryopreservation, General Purpose (8130) Thermo Scientific Forma Laboratory Refrigerators and Freezers (989) Thermo Scientific HeraFreeze ULT HFC1350TD CHST 230/60 (HFC1350TD) Thermo Scientific HeraFreeze ULT HFC350TV CHEST 230/50 (HFC350TV) Thermo Scientific Revco ULT DXF40040V UPRT 230/50 (DXF40040V) Thermo Scientific Upright Freezer ULT TSD40400V UPRT 230/50 (TSD40400V) Thermo Scientific Forma Plasma Freezer FFPF5030A, FFPF5030D, FFPF5030V, FFPF5030W Thermo Scientific Forma Laboratory Refrigerators and Freezers (988) Thermo Scientific Forma ULT 717CV CHEST 120/60 (717CA) Thermo Scientific HeraFreeze ULT HFU40240BD UP 230/60 (HFU40240BD) Thermo Scientific Revco ULT-1350-10-D -40 230/60 (ULT1350-10-D) Thermo Scientific Revco ULT2090-10-A CHST 120/60 (ULT2090-10-A) Thermo Scientific Revco Plasma Freezer UFP3030A, UFP3030D, UFP3030V, UFP3030W Thermo Scientific Revco Plasma Freezer UFP5030A, UFP5030D, UFP5030W Fisher Scientific ISOTemp ULT I913CV CHST 230/50 (I913CV) Thermo Scientific Forma Cryopreservation, General Purpose (7401) Thermo Scientific Forma ULT 713CA CHEST 120/60 (713CA) Thermo Scientific Forma ULT 7320V UPRIGHT 230/50 (7320V) Thermo Scientific Revco ULT1790-10-V CHST 230/50 (ULT1790-10-V) Thermo Scientific TSE Series ULT TSE320A UPRT 120/60 (TSE320A) Thermo Scientific Forma ULT 720CA CHEST 120/60 (720CA) Thermo Scientific HeraFreeze ULT HFU40320BA UP 120/60 (HFU40320BA) Thermo Scientific HeraFreeze ULT HFU40400BA UP 120/60 (HFU40400BA) Thermo Scientific Revco ULT2090-10-V CHST 230/50 (ULT2090-10-V) Thermo Scientific Chest Freezer ULT TSC1350A CHEST 120/60 (TSC1350A) Thermo Scientific Chest Freezer ULT TSC2050V CHEST 230/50 (TSC2050V) Thermo Scientific Forma Cryopreservation, General Purpose (7406) Thermo Scientific Forma ULT 803CV 03 CHEST 230/50 (803CV) Thermo Scientific HeraFreeze ULT HFC1390TD CHST 230/60 (HFC1390TD) Thermo Scientific ISOTemp ULT IU2386V UPRT 230/50 (IU2386V) Thermo Scientific TSE Series ULT TSE400V 23 UP 230/50 (TSE400V) Thermo Scientific Chest Freezer ULT TSC1750D CHEST 230/60 (TSC1750D) Thermo Scientific Forma Cryopreservation, General Purpose (7455) Thermo Scientific Forma ULT 820CA CHEST 120/60 (820CA) Thermo Scientific ISOTemp ULT IU1386D UPRT 230/60 (IU1386D) Thermo Scientific Revco ULT DXF32040D UPRT 230/60 (DXF32040D) Thermo Scientific Upright Freezer ULT TSD40320D UPRT 230/60 (TSD40320D) Fisher Scientific ISOTemp ULT 1917CD CHST 230/60 (I917CD) Thermo Scientific Chest Freezer ULT TSC1390D CHEST 230/60 (TSC1390D) Thermo Scientific Forma ULT 7240A UPRIGHT 120/60 (7240A) Thermo Scientific Forma Plasma Freezer FFPF1230A, FFPF1230V, FFPF1230W Thermo Scientific Forma ULT 817CA 17 CHEST 120/60 (817CA) Thermo Scientific HeraFreeze ULT HFU600BD UPRT 230/60 (HFU600BD) Thermo Scientific Revco ULT390-10-A CHST 120/60 (ULT390-10-A) Thermo Scientific Upright Freezer ULT TSD40240D UPRT 230/60 (TSD40240D) Fisher Scientific ISOTemp ULT I903CA CHST 120/60 (I903CA) Thermo Scientific Chest Freezer ULT TSC1750A CHEST 120/60 (TSC1750A) Thermo Scientific Forma Cryopreservation, General Purpose (7454) Thermo Scientific Forma ULT 817CV 17 CHEST 230/50 (817CV) Thermo Scientific ISOTemp ULT IU1386A UPRT 120/60 (IU1386A) Thermo Scientific Revco ULT DXF32040A UPRT 120/60 (DXF32040A) Thermo Scientific TSE Series ULT TSE240A UPRT 120/60 (TSE240A) Thermo Scientific Upright Freezer ULT TSD40320A UPRT 120/60 (TSD40320A) Thermo Scientific Forma ULT 717CV CHEST 230/50 (717CV) Thermo Scientific HeraFreeze ULT HFU40240BV UP 230/50 (HFU40240BV) Thermo Scientific HeraFreeze ULT HFU40320BV UP 230/50 (HFU40320BV) Thermo Scientific Revco ULT1350-10-V -40 230/50 (ULT1350-10-V) Thermo Scientific Revco ULT2090-10-D CHST 230/60 (ULT2090-10-D) Thermo Scientific Harris Freezer MBF700 Thermo Scientific Revco Plasma Freezer UFP1230A, UFP1230D, UFP1230V, UFP1230W Thermo Scientific Jewett Plasma Freezer JPL3030A, JPL3030D, JPL3030V, JPL3030W Thermo Scientific Jewett Plasma Freezer JPL5030A, JPL5030D, JPL5030V, JPL5030W Fisher Scientific ISOTemp ULT I917CV CHST 230/50 (I917CV) Thermo Scientific Forma Cryopreservation, General Purpose (7403) Thermo Scientific Forma ULT 7400D UPRIGHT 230/60 (7400D) Thermo Scientific ISOTemp ULT IU1786V UPRT 230/50 (IU1786V) Thermo Scientific TSE Series ULT TSE320V 17 UP 230/50 (TSE320V) Fisher Scientific ISOTemp ULT 1913CD CHST 230/60 (I913CD) Thermo Scientific Chest Freezer ULT TSC1390A CHEST 120/60 (TSC1390A) Thermo Scientific Forma ULT 720CV CHEST 230/50 (720CV) Thermo Scientific Forma ULT 813CV 12 CHEST 230/50 (813CV) Thermo Scientific HeraFreeze ULT HFU40400BV UP 230/50 (HFU40400BV) Thermo Scientific Revco ULT350-10-V -40 230/50 (ULT350-10-V) Thermo Scientific Upright Freezer ULT TSD40240A UPRT 120/60 (TSD40240A) Thermo Scientific Chest Freezer ULT TSC1750V CHEST 230/50 (TSC1750V) Thermo Scientific Forma Cryopreservation, General Purpose (7472) Thermo Scientific Forma ULT 820CD CHEST 230/60 (820CD) Thermo Scientific HeraFreeze ULT HFC2050TA CHST 120/60 (HFC2050TA) Thermo Scientific ISOTemp ULT IU1386V UPRT 230/50 (IU1386V) Thermo Scientific Revco ULT DXF32040V UPRT 230/50 (DXF32040V) Thermo Scientific Upright Freezer ULT TSD40320V UPRT 230/50 (TSD40320V) Thermo Scientific Chest Freezer ULT TSC2050A CHEST 120/60 (TSC2050A) Thermo Scientific Forma Laboratory Refrigerators and Freezers (902) Thermo Scientific Forma Laboratory Refrigerators and Freezers (990) Thermo Scientific HeraFreeze ULT HFC390TA CHEST 120/60 (HFC390TA) Thermo Scientific Revco ULT EXF24086A UPRT 120/60 (EXF24086A) Thermo Scientific Revco ULT1390-10-A CHST 120/60 (ULT1390-10-A) Fisher Scientific ISOTemp ULT I913CA CHST 120/60 (I913CA) Thermo Scientific Forma ULT 703CV CHEST 230/50 (703CV) Thermo Scientific Forma ULT 7320D UPRIGHT 230/60 (7320D) Thermo Scientific Revco ULT1790-10-D CHST 230/60 (ULT1790-10-D) Thermo Scientific TSE Series ULT TSE240V 13 UP 230/50 (TSE240V) Thermo Scientific Forma ULT 720CD CHEST 230/60 (720CD) Thermo Scientific Forma ULT 813CD 12 CHEST 230/60 (813CD) Thermo Scientific HeraFreeze ULT HFU40320BD UP 230/60 (HFU40320BD) Thermo Scientific HeraFreeze ULT HFU40400BD UP 230/60 (HFU40400BD) Thermo Scientific Revco ULT350-10-A -40 120/60 (ULT350-10-A) Thermo Scientific Forma Plasma Freezer FFPF3030A, FFPF3030D, FFPF3030V, FFPF3030W Thermo Scientific Revco Plasma Freezer UFP2330A, UFP2330D, UFP2330W Thermo Scientific Forma Laboratory Refrigerators and Freezers (986) Thermo Scientific Forma ULT 717CD CHEST 230/60 (717CD) Thermo Scientific HeraFreeze ULT HFU40240BA UP 120/60 (HFU40240BA) Thermo Scientific Revco ULT1350-10-A -40 120/60 (ULT1350-10-A) Thermo Scientific Revco ULT2050-10-V -40 230/50 (ULT2050-10-V) Thermo Scientific Chest Freezer ULT TSC350A CHEST 120/60 (TSC350A) Thermo Scientific Forma Cryopreservation, General Purpose (7452) Thermo Scientific Forma Laboratory Refrigerators and Freezers (908) Thermo Scientific HeraFreeze ULT HFC1750TV CHST 230/50 (HFC1750TV) Thermo Scientific HeraFreeze ULT HFU320BD UPRT 230/60 (HFU320BD) Thermo Scientific Revco ULT DXF24040D UPRT 230/60 (DXF24040D) Thermo Scientific Revco ULT EXF40086A UPRT 120/60 (EXF40086A) Thermo Scientific Forma Laboratory Refrigerators and Freezers (993) Thermo Scientific HeraFreeze ULT HFU240BD UPRT 230/60 (HFU240BD) Thermo Scientific Revco ULT EXF32086A UPRT 120/60 (EXF32086A) Thermo Scientific Revco ULT1750-10-A -40 120/60 (ULT1750-10-A) Thermo Scientific Forma Laboratory Refrigerators and Freezers (904) Thermo Scientific Forma Laboratory Refrigerators and Freezers (992) Thermo Scientific HeraFreeze ULT HFU240BA UPRT 120/60 (HFU240BA) Thermo Scientific Revco ULT EXF24086V UPRT 230/50 (EXF24086V) Thermo Scientific Revco ULT1390-10-V CHST 230/50 (ULT1390-10-D) Thermo Scientific Chest Freezer ULT TSC390V CHEST 230/50 (TSC390V) Thermo Scientific Forma Laboratory Refrigerators and Freezers (956) Thermo Scientific Forma ULT 713CD CHEST 230/60 (713CD) Thermo Scientific HeraFreeze ULT HFC1790TV CHST 230/50 (HFC1790TV) Thermo Scientific HeraFreeze ULT HFU400BD UPRT 230/60 (HFU400BD) Thermo Scientific Revco ULT EXF60086D UPRT 230/60 (EXF60086D) Thermo Scientific Chest Freezer ULT TSC2090V CHEST 230/50 (TSC2090V) Thermo Scientific Forma Cryopreservation, General Purpose (7451) Thermo Scientific Forma Laboratory Refrigerators and Freezers (907) Thermo Scientific HeraFreeze ULT HFC1750TD CHST 230/60 (HFC1750TD) Thermo Scientific Revco ULT DXF24040A UPRT 120/60 (DXF24040A) Thermo Scientific Revco ULT EXF32086V UPRT 230/50 (EXF32086V) Thermo Scientific Forma Laboratory Refrigerators and Freezers (903) Thermo Scientific Forma Laboratory Refrigerators and Freezers (991) Thermo Scientific HeraFreeze ULT HFC390TV CHEST 230/50 (HFC390TV) Thermo Scientific Revco ULT EXF24086D UPRT 230/60 (EXF24086D) Thermo Scientific Revco ULT1390-10-D CHST 230/60 (ULT1390-10-V) Thermo Scientific Forma Laboratory Refrigerators and Freezers (994) Thermo Scientific HeraFreeze ULT HFU240BV UPRT 230/50 (HFU240BV) Thermo Scientific Revco ULT1750-10-D -40 230/60 (ULT1750-10-D) Thermo Scientific Chest Freezer ULT TSC1790D CHEST 230/60 (TSC1790D) Thermo Scientific Forma Cryopreservation, General Purpose (7474) Thermo Scientific HeraFreeze ULT HFC1350TA CHST 120/60 (HFC1350TA) Thermo Scientific HeraFreeze ULT HFC350TA CHEST 120/60 (HFC350TA) Thermo Scientific Revco ULT DXF40040D UPRT 230/60 (DXF40040D) Thermo Scientific Upright Freezer ULT TSD40400D UPRT 230/60 (TSD40400D) Thermo Scientific Forma Laboratory Refrigerators and Freezers (995) Thermo Scientific Forma ULT 7240V UPRIGHT 230/50 (7240V) Thermo Scientific HeraFreeze ULT HFU320BA UPRT 120/60 (HFU320BA) Thermo Scientific Revco ULT1750-10-V -40 230/50 (ULT1750-10-V) Thermo Scientific Jewett Plasma Freezer JPL2330A, JPL2330D, JPL2330V, JPL2330W Thermo Scientific Revco Plasma Freezer UFP430A, UFP430V, UFP430W Thermo Scientific Digital Baths General Purpose (TSGP02) Thermo Scientific Forma Incubators, General Purpose (3542) Fisher Scientific ISOTemp Baths General Purpose (FSGPD15D) Thermo Scientific Forma Incubators, General Purpose (3057) Thermo Scientific Forma Incubators, General Purpose (3428) Fisher Scientific ISOTemp Baths General Purpose (FSSWB27) Thermo Scientific Forma Incubators, General Purpose (3951) Fisher Scientific ISOTemp Baths General Purpose (FSGPD10) Thermo Scientific Forma Incubators, General Purpose (3020) Thermo Forma Cell Rollers (4862) Thermo Scientific Forma Gas Guard (3050) Thermo Scientific Forma Incubators, General Purpose (370) Thermo Scientific Incubators, General Purpose (3948) Fisher Scientific ISOTemp Incubators, General Purpose (FB3532DH) Thermo Scientific Digital Baths General Purpose (TSGP28) Thermo Scientific Incubators, General Purpose (3907) Thermo Scientific Digital Baths General Purpose (TSGP20) Thermo Scientific Forma Incubators, General Purpose (3405) Fisher Scientific ISOTemp Baths General Purpose (FSGPD02) Thermo Forma Cell Rollers (4868) Thermo Scientific Forma HI-TMP BATH 160A 11-481 -A- (88151Q) Thermo Scientific Forma Incubators, General Purpose (3308) Thermo Scientific Forma Incubators, General Purpose (3541) Thermo Scientific Forma Incubators, General Purpose (3423) Thermo Scientific Forma Incubators, General Purpose (380) Thermo Scientific Shaking Baths General Purpose (TSDUB15) Fisher Scientific ISOTemp Incubators, General Purpose (FB3531WJ) Thermo Scientific Forma Incubators, General Purpose (3961) Thermo Scientific Circulating Baths General Purpose (TSCIR35) Thermo Scientific Shaking Baths General Purpose (TSSWB15S) Fisher Scientific ISOTemp Baths General Purpose (FSGPD05) Thermo Scientific Forma Incubators, General Purpose (3010) Thermo Scientific Digital Baths General Purpose (TSGP10) Thermo Scientific Forma Incubators, General Purpose (3311) Thermo Scientific Coliform Baths General Purpose (TSCOL35) Thermo Scientific Digital Baths General Purpose (TSGP05) Thermo Scientific Forma Incubators, General Purpose (3310) Thermo Scientific Circulating Baths General Purpose (TSCIR19) Thermo Scientific Forma Incubators, General Purpose (381) Thermo Scientific Shaking Baths General Purpose (TSSWB15) Fisher Scientific ISOTemp Incubators, General Purpose (FB3533DH) Thermo Scientific Digital Baths General Purpose (TSGP2S) Thermo Scientific Coliform Baths General Purpose (TSCOL19) Thermo Scientific Digital Baths General Purpose (TSGP15D) Thermo Scientific Forma Incubators, General Purpose (3403) Thermo Scientific Forma Incubators, General Purpose (3424) Thermo Scientific Forma Incubators, General Purpose (3911) Fisher Scientific ISOTemp Incubators, General Purpose (FB3530WJ) Thermo Scientific Forma Incubators, General Purpose (3960) Thermo Scientific Circulating Baths General Purpose (TSCIR89) Thermo Scientific Shaking Baths General Purpose (TSSWB27) Thermo Scientific Forma Incubators, General Purpose (371) Thermo Scientific Incubators, General Purpose (3962) Thermo Scientific Forma Incubators, General Purpose (3307) Thermo Scientific Forma Incubators, General Purpose (3540) Fisher Scientific ISOTemp Baths General Purpose (FSGPD28) Thermo Scientific Forma Incubators, General Purpose (3427) Thermo Scientific Forma Incubators, General Purpose (3940) Thermo Scientific Forma Incubators, General Purpose (3426) Thermo Scientific Forma Incubators, General Purpose (3920) Thermo Scientific Forma Incubators, General Purpose (3543) Fisher Scientific ISOTemp Baths General Purpose (FSGPD20) Thermo Scientific Forma Incubators, General Purpose (3063) Thermo Scientific Forma Incubators, General Purpose (3429) Thermo Scientific Forma Incubators, General Purpose (3425) Thermo Scientific Forma Incubators, General Purpose (3913) Fisher Scientific ISOTemp Baths General Purpose (FSGPD2S) Thermo Scientific Forma Incubators, General Purpose (3949) Thermo Scientific Forma Incubators, General Purpose (3422) Fisher Scientific ISOTemp Baths General Purpose (FSSWB15) Thermo Scientific Forma Incubators, General Purpose (3950) Thermo Forma Anaerobic System (1037) Thermo Scientific Forma Anaerobic System (931024) Thermo Forma Anaerobic System (1018) Thermo Forma Anaerobic System (1029) Thermo Forma Anaerobic System (1016) Thermo Forma Anaerobic System (1031) Thermo Forma Anaerobic System (1025) Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX70086MA Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX40086MA Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LV Thermo Scientific Plasma Freezer TSX2330LV, TSX2330LY, TSX2330LZ Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE50086LA, IUE50086LD, IUE50086LV Thermo Scientific CryoMed TSCM48MA (CryoMed MD 48L w/o print 120v) Thermo Scientific CryoMed TSCM34EL (CryoMed MD 34L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LD HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE40040LA, HDE40040LD,HDE40040LV Thermo Scientific CryoMed TSCM17TA (CRF CTS MD 17L w/print 120V) Thermo Scientific HERAFreeze Freezers HDE60086LA Thermo Scientific Forma Blood Bank Refrigerator FRBB3004A, FRBB3004D, FRBB3004V, FRBB3004W Thermo Scientific Blood Bank Refrigerators TSX1204BA, TSX1204BD, TSX1204BV Thermo Scientific CryoMed TSCM48EA (CryoMed MD 48L w/ print 120v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LA, TSX2330LD Thermo Scientific CryoMed TSCM48MV (CryoMed MD 48L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LA, TSX3030LD Thermo Scientific Revco Freezers RDE50086LA, RDE50086LD, RDE50086LV, RDE60086LA, RDE60086LD, RDE60086LV Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE60040LA, TDE60040LD, TDE60040LV Thermo Scientific Forma Freezers FDE50086LA, FDE50086LD, FDE50086LV, FDE60086LA, FDE60086LD, FDE60086LV Thermo Scientific Revco Blood Bank Refrigerator REB5004A, REB5004D, REB5004V, REB5004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LA Thermo Scientific CryoMed TSCM34MV (CryoMed MD 34L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LA, TSX1230LD Thermo Scientific Revco Freezers RDE30086LA, RDE30086LD, RDE30086LV, RDE40086LA, RDE40086LD, RDE40086LV Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE60040LA, RDE60040LD, RDE60040LV Thermo Scientific CryoMed TSCM17EV (CryoMed MD 17L w/ print 230v) Thermo Scientific HERAFreeze Freezers HDE50086LD, HDE50086LV, HDE60086LD, HDE60086LV Thermo Scientific Revco Blood Bank Refrigerator REB2304A, REB2304D, REB2304V, REB2304W Thermo Scientific CryoMed TSCM48TA (CRF CTS MD 48L w/print 120V) Ultra-Low Temperature Freezer TDEC06386LV Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BA, TSX2304BD, TSX2304BV Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE40040LA, FDE40040LD, FDE40040LV Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE60086LA, IUE60086LD, IUE60086LV Thermo Scientific HERAFreeze Freezers HDE50086LA Thermo Scientific Forma Blood Bank Refrigerator FRBB1204A, FRBB1204D, FRBB1204V, FRBB1204W Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE40040LA, RDE40040LD, RDE40040LV Thermo Scientific CryoMed TSCM34CA (CRF CTS MD 34L w/o print 120V) Ultra-Low Temperature Freezer TDEC25286LV Thermo Scientific Jewett Blood Bank Refrigerator JBB5004A, JBB5004D, JBB5004V, JBB5004W VWR Series Chest Ultra-Low Temperature Freezer VWRC25286LD Thermo Scientific Blood Bank Refrigerators TSX2304BY, TSX2304BZ Thermo Scientific Freezers TDE50086LA, TDE50086LD, TDE50086LV, TDE60086LA, TDE60086LD, TDE60086LV Thermo Scientific CryoMed TSCM34EA (CryoMed MD 34L w/ print 120v) Ultra-Low Temperature Freezer TDEC25286LA Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LA Thermo Scientific Revco Ultra Low Temperature Freezer RDE60086MA, RDE60086MD, RDE60086MV Ultra-Low Temperature Freezer TDEC39686LD Thermo Scientific Revco Blood Bank Refrigerator REB404D, REB404V, REB404W Thermo Scientific CryoMed TSCM34TA (CRF CTS MD 34L w/print 120V) Ultra-Low Temperature Freezer TDEC39686LA Thermo Scientific Jewett Blood Bank Refrigerator BBR25D-2A Thermo Scientific Plasma Freezer TSX5030LV, TSX5030LY, TSX5030LZ Thermo Scientific Plasma Freezer TSX3030LV, TSX3030LY, TSX3030LZ Thermo Scientific Forma Freezers FDE30086LA, FDE30086LD, FDE30086LV, FDE40086LA, FDE40086LD, FDE40086LV Thermo Scientific Forma Blood Bank Refrigerator FRBB2304A, FRBB2304D, FRBB2304V, FRBB2304W Thermo Scientific Forma Ultra Low Temperature Freezer FDE60086MA, FDE60086MD, FDE60086MV Ultra-Low Temperature Freezer TDEC39686LV Thermo Scientific Blood Bank Refrigerators TSX3004BY, TSX3004BZ Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A, JBB1204D, JBB1204V, JBB1204W Thermo Scientific Blood Bank Refrigerators TSX1204BY, TSX1204BZ Thermo Scientific Freezers TDE30086LA, TDE30086LD, TDE30086LV, TDE40086LA, TDE40086LD, TDE40086LV Thermo Scientific TSX Universal Series ULT Freezer TSX40086LA Thermo Scientific CryoMed TSCM17MV (CryoMed MD 17L w/o print 230v) Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LA, TSX5030LD Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE50040LA, FDE50040LD, FDE50040LV Thermo Scientific CryoMed TSCM34EV (CryoMed MD 34L w/ print 230v) Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BA, TSX5004BD, TSX5004BV Thermo Scientific TSX Universal Series ULT Freezer TSX50086LA Thermo Scientific HERAfreeze Ultra Low Temperature Freezer HDE60086MA, HDE60086MD, HDE60086MV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LA Thermo Scientific Blood Bank Refrigerators TSX5004BY, TSX5004BZ Thermo Scientific CryoMed TSCM17EA (CryoMed MD 17L w/ print 120v) Thermo Scientific CryoMed TSCM48EL (CryoMed MD 48L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LV Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC25286LD Thermo Scientific Plasma Freezer TSX1230LV, TSX1230LY, TSX1230LZ Thermo Scientific CryoMed TSCM17CA (CRF CTS MD 17L w/o print 120V) Ultra-Low Temperature Freezer TDEC06386LA Thermo Scientific Plasma Blast Freezer XBF40D-MD Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE40086LA, IUE40086LD, IUE40086LV Thermo Scientific CryoMed TSCM34MA (CryoMed MD 34L w/o print 120v) Thermo Scientific CryoMed TSCM17EL (CryoMed MD 17L w/ print 100v) Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC39686LA Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-2A Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE40040LA, TDE40040LD, TDE40040LV Thermo Scientific Ultra Low Temperature Freezer TDE60086MA,TDE60086MD, TDE60086MV Thermo Scientific CryoMed TSCM34ML (CryoMed MD 34L w/o print 100v) Thermo Scientific Forma Blood Bank Refrigerator FRBB404A, FRBB404V, FRBB404W VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LD Thermo Scientific Revco RDE Series -40 C Ultra-Low Temperature Freezers RDE50040LA, RDE50040LD, RDE50040LV Thermo Scientific CryoMed TSCM48CA (CRF CTS MD 48L w/o print 120V) Ultra-Low Temperature Freezer TDEC25286LD Thermo Scientific HERAFreeze Freezers HDE30086LA Thermo Scientific Revco Blood Bank Refrigerator REB1204D, REB1204V, REB1204W Thermo Scientific TSX Universal Series ULT Freezer TSX60086LA VWR Series Chest Ultra-Low Temperature Freezer VWRC39686LA HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE50040LA, HDE50040LD,HDE50040LV Thermo Scientific CryoMed TSCM48EV (CryoMed MD 48L w/ print 230v) Thermo Scientific Jewett Blood Bank Refrigerator JBB404A, JBB404D, JBB404V, JBB404W Thermo Scientific Forma FDE Series -40 C Ultra-Low Temperature Freezers FDE60040LA, FDE60040LD, FDE60040LV Thermo Scientific CryoMed TSCM17ML (CryoMed MD 17L w/o print 100v) Thermo Scientific Forma Blood Bank Refrigerator FRBB5004A, FRBB5004D, FRBB5004V, FRBB5004W Thermo Scientific Revco Blood Bank Refrigerator REB3004A, REB3004D, REB3004V, REB3004W Thermo Scientific TSX Universal Series ULT Freezer TSX70086LA Thermo Scientific TDE Series -40 C Ultra-Low Temperature Freezers TDE50040LA, TDE50040LD, TDE50040LV Thermo Scientific HERAFreeze Freezers HDE40086LA Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-1B VWR Series Chest Ultra-Low Temperature Freezer VWRC06386LA HERAfreeze HDE Series -40 C Ultra-Low Temperature Freezers HDE60040LA, HDE60040LD,HDE60040LV Thermo Scientific HERAFreeze Freezers HDE30086LD, HDE30086LV, HDE40086LD, HDE40086LV, Thermo Scientific Jewett Blood Bank Refrigerator JBB2304A, JBB2304D, JBB2304V, JBB2304W Fisherbrand Isotemp Ultra-Low-Temperature Freezers IUE30086LA, IUE30086LD, IUE30086LV Thermo Scientific CryoMed TSCM17MA (CryoMed MD 17L w/o print 120v) Thermo Scientific CryoMed TSCM48ML (CryoMed MD 48L w/o print 100v) Thermo Scientific Jewett Blood Bank Refrigerator JBB3004A, JBB3004D, JBB3004V, JBB3004W Fisherbrand Isotemp Ultra Low Temperature Freezer IUEC06386LV Thermo Scientific Blood Bank Refrigerators TSX3004BA, TSX3004BD, TSX3004BV Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX60086MA Thermo Scientific TSX Core Series Ultra-Low Temperature Freezer TSX50086MA Thermo Scientific Forma Incubator, Direct Heat, ivf (320) Thermo Scientific Forma Incubator, Direct Heat, ivf (361) Thermo Scientific Forma Incubator, Direct Heat, ivf (360) Thermo Scientific Forma Incubator, Direct Heat, ivf (350) Thermo Scientific Forma Incubator, Direct Heat, ivf (311) Thermo Scientific Forma Incubator, Direct Heat, ivf (321) Thermo Scientific Forma Incubator, Direct Heat, ivf (310) Thermo Scientific Forma Incubator, Direct Heat, ivf (351) Thermo Scientific MaxQ Reciprocating Shaker 120V (SHKA2506) Thermo Scientific MaxQ Dual Action Shaker 120V (SHKA2508) U-TURN, Mek INTERNAL U-TURN PARALLEL BYPASS OLYMPUS AU680 RECAPPER 110 VAC 60 HZ Parallel Bypass TOSOH G8 TCA 800 INTERFACE FOR COBAS 8000 ALIQUOTER AND LABELLER LOADER, product no. 952312 Z-TURN, LEFT EXIT INTERFACE ImmunoCap 1000 CONVEYOR 1200 MM ENTRY Procleix Reagent Preparation Incubator RPI 250 (120V & 220-240V) CONVEYOR 2100 MM PARALLEL BYPASS LIAISON XL SYSMEX HST Interface DECAPPER FLEX INTERFACE ARCHITECT C8000 Z-TURN, RIGHT STAGO STA-R INTERFACE CONVEYOR 1800 MM PERPENDICULAR BYPASS, TCA for COLD STORAGE RACK LOADER, product no. 952292 T-TURN PARALLEL BYPASS TOSOH CENTRIFUGE MODULE PARALLEL BYPASS BECKMAN Unicel Dxl 800 ES Flex PARALLEL BYPASS FOR ACL Top STORAGE, product no. 952311 PARALLEL BYPASS VITROS 5.1 FS BUFFER CONVEYOR 900 MM CONVEYOR 2400 MM CONVEYOR 600 MM Propleix Reagent Preparation Incubator RPI (120V & 220-240V) CONVEYOR 1500 MM L-TURN LAS PC Win10 including SW TCA CONTROLLER PC Including SW Win10 INTERFACE ARCHITECT i2000SR PERPENDICULAR BYPASS VITROS 5.1 FS BULK INTERFACE MODULE CENTRIFUGE FLEX MODULE Thermo Scientific Forma Incubator, Water Jacket, ivf (3111) Thermo Scientific Forma Incubator, Water Jacket, ivf (3130) Thermo Scientific Forma Incubator, Water Jacket, ivf (3110) Thermo Scientific Forma Incubator, Water Jacket, ivf (3140) Thermo Scientific Forma Incubator, Water Jacket, ivf (3131) Thermo Scientific Forma Incubator, Water Jacket, ivf (3120) Thermo Scientific Forma Incubator, Water Jacket, ivf (3141) Thermo Scientific Forma Incubator, Water Jacket, ivf (3121) Thermo Scientific Forma Controlled Rate Freezer (7475) Thermo Scientific Forma Controlled Rate Freezer (7476) Thermo Scientific Forma Controlled Rate Freezer (7457) Thermo Scientific Forma Controlled Rate Freezer (7456) Thermo Scientific Forma Controlled Rate Freezer (7458) Thermo Scientific Forma Controlled Rate Freezer (7459)

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)