FDA Registration
Active
🇺🇸 United States
PARALLEL BYPASS FOR ACL Top
Reg #: 1523845
·
FEI: 1523845
·
Expires 2025
Products
1
Proprietary Names
44
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
- Registration Number
- 1523845
- FEI Number
- 1523845
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 401 MILLCREEK RD.
- City
- MARIETTA
- State
- OH
- ZIP
- 45750
- Country
- US
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 |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2004-09-22 |
Proprietary Names
PARALLEL BYPASS FOR ACL Top
PARALLEL BYPASS LIAISON XL
PARALLEL BYPASS BECKMAN Unicel Dxl 800
U-TURN, Mek
INTERNAL U-TURN
RECAPPER 110 VAC 60 HZ
SYSMEX HST Interface
DECAPPER FLEX
INTERFACE ARCHITECT C8000
ALIQUOTER AND LABELLER
BUFFER
CONVEYOR 900 MM
PARALLEL BYPASS TOSOH
CENTRIFUGE MODULE
TCA 800 INTERFACE FOR COBAS 8000
PERPENDICULAR BYPASS VITROS 5.1 FS
PERPENDICULAR BYPASS, TCA for COLD STORAGE RACK LOADER, product no. 952292
CONVEYOR 1200 MM
ENTRY
Propleix Reagent Preparation Incubator RPI (120V & 220-240V)
Procleix Reagent Preparation Incubator RPI 250 (120V & 220-240V)
ES Flex
Parallel Bypass TOSOH G8
PARALLEL BYPASS OLYMPUS AU680
STAGO STA-R INTERFACE
CONVEYOR 1800 MM
CONVEYOR 2100 MM
Z-TURN, RIGHT
CONVEYOR 600 MM
STORAGE, product no. 952311
PARALLEL BYPASS VITROS 5.1 FS
LAS PC Win10 including SW
Z-TURN, LEFT
T-TURN
INTERFACE ARCHITECT i2000SR
TCA CONTROLLER PC Including SW Win10
INTERFACE ImmunoCap 1000
LOADER, product no. 952312
BULK INTERFACE MODULE
CONVEYOR 1500 MM
CONVEYOR 2400 MM
L-TURN
EXIT
CENTRIFUGE FLEX MODULE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)