FDA Registration
Active
🇺🇸 United States
BECKMAN COULTER, INC.
Reg #: 2122870
·
FEI: 2122870
·
Expires 2026
Products
69
Proprietary Names
271
Establishment Types
4
Classifications
69
Registration Details
- Registration Name
- BECKMAN COULTER, INC.
- Registration Number
- 2122870
- FEI Number
- 2122870
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1000 LAKE HAZELTINE DR.
- City
- CHASKA
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K954680
- PMA Number
- P980041
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 1992-07-14 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2008-08-14 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2008-08-14 |
| Radioimmunoassay, Parathyroid Hormone | CEW | Class 2 | Clinical Chemistry | No | 2008-08-14 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2008-09-18 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2012-09-21 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2023-12-20 |
| Radioassay, Intrinsic Factor Blocking Antibody | LIG | Class 2 | Clinical Chemistry | No | 2024-05-14 |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | Class 3 | Unknown | No | 2006-09-05 |
| System, Test, Immunological, Antigen, Tumor | MOI | Class 2 | Immunology | No | 2024-05-14 |
| Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | LTK | Class 2 | Immunology | No | 2024-05-14 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2024-08-15 |
| Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | CIN | Class 2 | Clinical Chemistry | No | 2024-04-25 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2012-09-21 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2024-09-17 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 2024-09-17 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 1992-07-14 |
| Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | LTJ | Class 2 | Immunology | No | 2006-09-05 |
| Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | MTF | Class 3 | Unknown | No | 2006-09-05 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2024-09-24 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 1999-04-28 |
| Radioimmunoassay, Free Thyroxine | CEC | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Radioimmunoassay, Cortisol | CGR | Class 2 | Clinical Chemistry | No | 2014-03-14 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2014-03-14 |
| System, Test, Thyroglobulin | MSW | Class 2 | Immunology | No | 2023-11-22 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 1999-04-28 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2012-09-21 |
| Enzyme Immunoassay, Digoxin | KXT | Class 2 | Clinical Toxicology | No | 2008-09-18 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | Class 2 | Clinical Chemistry | No | 2012-09-21 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2014-08-18 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2014-08-18 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2014-08-18 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2014-08-18 |
| System, Test, Carcinoembryonic Antigen | DHX | Class 2 | Immunology | No | 2023-11-22 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2007-06-07 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2023-09-22 |
| System, Test, Vitamin D | MRG | Class 2 | Clinical Chemistry | No | 2015-01-22 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2008-09-18 |
| Assay, Erythropoietin | GGT | Class 2 | Hematology | No | 2024-04-25 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2006-07-24 |
| P2psa | OYA | Class 3 | Unknown | No | 2013-11-21 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2002-04-24 |
| Radioimmunoassay, Thyroxine-Binding Globulin | CEE | Class 2 | Clinical Chemistry | No | 2012-09-21 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2026-03-25 |
| Enzyme Immunoassay, Inhibin-A | NDR | Class 1 | Clinical Chemistry | No | 2007-04-24 |
| Counter, Urine Particle | LKM | Class 2 | Hematology | No | 2014-07-16 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2008-08-14 |
| System, Test, Human Chorionic Gonadotropin | DHA | Class 2 | Clinical Chemistry | No | 2014-06-20 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-06-20 |
| Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission | PTF | Class 2 | Microbiology | No | 2023-05-01 |
| Radioimmunoassay (Two-Site Solid Phase), Ferritin | JMG | Class 2 | Immunology | No | 2007-06-07 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 1992-07-14 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2012-09-21 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 1977-12-14 |
| Counter, Cell, Automated (Particle Counter) | GKL | Class 2 | Hematology | No | 2019-04-09 |
| System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | NIG | Class 2 | Immunology | No | 2008-09-18 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2023-08-31 |
| Immunochemical, Thyroglobulin Autoantibody | JNL | Class 2 | Immunology | No | 2024-07-23 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2008-09-18 |
| Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | MTG | Class 3 | Unknown | No | 2008-09-18 |
Proprietary Names
Access Sensitive Estradiol (P/N: B84493 IE MFG)
Access Estradiol (33540 MN ans IE MFG)
Access Prolactin (P/N: 33530 MN and IE MFG)
Access Prolactin Calibrators (P/N: 33535 MN MFG)
Access Intact PTH (P/N: A16972 MN and IE MFG)
Access Intact PTH Calibrators (P/N: A16953 FR MFG)
Access Testosterone (P/N: 33560)
Access Testosterone Calibrators (P/N: 33565)
Access Rubella IgG (P/N: 34430)
Access Rubella IgG QC (P/N: 34439)
Access Rubella IgG Calibrators (P/N: 34435)
Access hsTnI (P/N: B52699 MN and IE MFG)
Access Intrinsic Factor Ab (P/N: 387992)
Access AFP (P/N: 33211)
Access AFP Sample Diluent (P/N: 33216)
Access BR Monitor (P/N: 387620)
Access TPO Antibody (P/N: A12985 MN and IE MFG)
Access Ostase (P/N: 37300)
Access Hybritech PSA QC (P/N: 37209)
Access Intrinsic Factor Antibody (P/N: 387992)
Access Intrinsic Factor Antibody QC (P/N: 387999)
Access Intrinsic Factor Antibody Calibrators (P/N: 387993)
Access Total T3 (P/N: 33830)
Access Total T3 Calibrators (P/N: 33835)
Access DHEA-S Calibrators (P/N: A10827)
Access DHEA-S (P/N: A10826)
Access Hybritech PSA Sample Diluent (P/N: 37206 MN MFG)
Access Hybritech PSA (P/N: 37200 MN and IE MFG)
Access Hybritech PSA Calibrators (P/N: 37205 MN MFG)
Access Hybritech PSA (P/N: C22845 MN MFG)
Access Inhibin A Calibrators (P/N: A36098)
Access Inhibin A QC (P/N: A36100)
Access OV Monitor (P/N: 386357)
Access Syphilis (P/N: C80411)
Access Ultrasensitive hGH (P/N: 33580)
UniCel DxI 800 Access Immunoassay System (P/N: 973100)
Access Thyroglobulin Calibrators (P/N: 33865)
Access Thyroglobulin Sample Diluent (P/N: 33866)
Access Thyroglobulin (C71762)
Access Ultrasensitive Insulin (P/N: 33410)
Access Ultrasensitive Insulin Calibrators (P/N: 33415)
Access Toxo IgM II QC (P/N: 34479)
Access Toxo IgM II (P/N: 34470)
Access Toxo IgM II Calibrators (P/N: 34475)
Access Digoxin (P/N: 33710)
Access Digoxin S0 Calibrator (P/N: 33716)
Access Digoxin Calibrators (P/N: 33715)
Access TPO Antibody Calibrators (P/N: A18227 FR MFG)
UniCel DxI 600 Access Immunoassay System (P/N: A30260)
UniCel DxI 600 Access Immunoassay System w/ Dual Gantry (P/N: A71461)
UniCel DxI 800 Access Immunoassay System w/ Dual Gantry (P/N: A71457)
UniCel DxI 800 Access Immunoassay System w/ Spot B Gantry (P/N: A71456)
UniCel DxI 600 Access Immunoassay System w/ Spot B Gantry (P/N: A71460)
Access AccuTnI +3 for use on the UniCel DxI Immunoassay Systems. (P/N: A98264)
Access AccuTnI +3 Calibrators for use on the UniCel DxI Immunoassay Systems.(P/N: A98265)
Access Total T4 II C69047
Access Total T4 Calibrators (P/N: 33805)
Access Total T4 (P/N: 33800)
Access Total T4 II Calibrators C69048
iChemVELOCITY Automated Urine Chemistry System (800-7167)
Stand-Alone iChemVELOCITY (800-7719)
iChemVELOCITY Automated Urine Chemistry System w load/unload (800-7166)
iChemVELOCITY Computerless (800-3530)
Back-Integrated iChemVELOCITY (800-7720)
iChemVELOCITY Urine Chemistry Strips (800-7212)
UA Win10 Kit (C52900)
Access Free T4 (P/N: C76421 MN and IE MFG)
Access Free T4 Calibrators (P/N: 33885 MN MFG)
Access CEA (P/N: 33200)
Access Cortisol S0 Calibrator (P/N: 33606)
Access Cortisol Calibrators (P/N:33605)
Access Cortisol (P/N: 33600)
Access Toxo IgM II (PN: 34470)
Access hFSH (P/N: 33520 MN and IE MFG)
Access hFSH Calibrators (P/N: 33525 MN and IE MFG)
Access AccuTnI +3 for Use on the Access 2 Immunoassay System (P/N: A98143)
Access 2 Immunoassay System (P/N: 81600N)
Access AccuTnI +3 Calibrators for use on the Access 2 Immunoassay System (P/N A98144)
Access CEA QC (P/N: 33029)
Access CEA Diluent (P/N: 33206)
Access CEA Calibrators (P/N: 33205)
Access Myoglobin (P/N: 973243 MN and IE MFG)
Access SHBG (P/N: A48617)
Access SHBG (P/N: A48617 MN MFG)
Access SHBG Calibrators
Access SHBG Calibrators (P/N: A48618 FR MFG)
Access SHBG QC (P/N: A48619 FR MFG)
Access SHBG QC
Access 25(OH) Vitamin D Total for Use on the Access 2 Immunoassay System (P/N: B24838 MN and IE MFG)
Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immunoassay System. (P/N: B24839 MN MFG)
Access sTFR (P/N: A32493)
Access sTFR Calibrators (P/N: A32494)
Access EPO (P/N: A16364)
PerFix NC Kit (Fixative Reagent)
447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4
A28945 SYNCHRON Systems ISE Electrolyte Buffer
657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300)
UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG)
445865 SYNCHRON Systems Wash Concentrate II
472137 SYNCHRON and AU Systems Hemolyzing Reagent
447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1
Iris® System Cleanser Pack (800-3203)
447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3
447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2
598190 598190 Trace-Klean Ready to Use Cleaning Solution
447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2
589784 Trace-Klean Concentrated Cleaning Solution
A28937 SYNCHRON Systems ISE Electrolyte Reference
A88469 HbDIL DxC
iChem® VELOCITY Wash Solution Case of 2 x 7L (800-7217)
Iris® Diluent Pack (800-3202)
467826 Sample Diluent 1 DIL1
447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1
469110 Synchron Systems NO FOAM
447060 IMMAGE Immunochemistry Systems Wash Solution
445967 SYNCHRON CX Systems Antifoam
442831 PVT 2, 472055 PVT 5, 442830 PVT 3
DTCS Quick Start Kit
DNA Size Standard Kit - 400
DNA Size Standard Kit - 600
Separation Buffer
SEPARATION GEL-LPA I
CEQ Sample Loading Solution
Separation Gel LPAI
DNA Sequencing Separation Buffer
Sample Loading Solution (SLS)
DNA Size Standard Kit - 80
GenomeLab GeXP Start Kit
iQ Body Fluids Lysing Reagent (800-3213)
iQ Lamina 2 x 7L (800-3236)
iQ Body Fluids Conical Tubes (800-3215)
66039 Cleaning Solution
664090 CLENZ Solution
Access Wash Buffer II ( P/N: A16972 KY and DE MFG)
Access Substrate (P/N: 81906 MN MFG)
Flow Check Pro Fluorospheres
UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG)
Access Sample Diluent A (P/N: 81908 MN MFG)
FLOW-CHECK
Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG)
LumiPhos PRO Substrate (P/N: B96000 MN MFG)
DxFLEX Daily QC Fluorospheres
ODR2000 5L WASH SOLUTION
OSR62166 LIH
OSR0001 WASH SOLUTION
657197 Synchron AUTO-GLOSS CTS
Access p2PSA Calibrators (P/N: B03705)
Access p2PSA (P/N: B03704)
Access Myoglobin Calibrators (P/N: 973244 MN MFG)
Access TSH (3rd IS) (P/N: B63284 MN and IE MFG)
DxI 9000 Immunoassay Analyzer (P/N: C11137)
Access TSH (3rd IS) (P/N: C28643 MN MFG)
Access hLH Calibrators (P/N: 33515 MN MFG)
Access hLH (P/N: 33510 MN and IE MFG)
Access Thyroid Uptake (P/N: 33810)
Access Thyroid Uptake Calibrators (P/N: 33815)
Access BNP II
Access Thyroglobulin (P/N: 33860)
ACCESS INHIBIN A (P/N: A36097)
Access 2 Immunoassay System (Refurbished P/N: 386220)
Access 2 Immunoassay system (P/N: 81600N)
Access Free T3 (P/N: A13422 MN and IE MFG)
IQ200 SPRINT 2008 TESTED (700-3325)
Velocity Instrument, 2nd Gen SRM, Bringup and Test Stand Alone (B75503)
Velocity Instrument, 2nd Gen SRM, Bringup and Test Computerless (B75502)
iQ200 Elite Automated Urine Microscopy Analyzer (800-3052; 800-3934; 800-3052; 800-3934)
iQ200 Sprint Automated Urine Microscopy Analyzer (800-3053; 800-3933; 800-3053; 800-3933)
iQ200 Select Automated Urine Microscopy Analyzer (800-3935; 800-3051)
DxU 850m Iris Automated Urine Microscopy Analyzer (PN C49513)
DxU 840m Iris Automated Urine Microscopy Analyzer (PN C76947)
Access Vitamin B12 (P/N: 33000 MN and IE MFG)
Access Vitamin B12 Calibrators (P/N: 33005 MN MFG)
Access Vitamin B12 S0 Calibrator (P/N: 33006 MN MFG)
Access Total bhCG (5th IS) (P/N: A85264 MN and IE MFG)
Access Total bhCG (5th IS) Calibrators (P/N: B11754 MN MFG)
Access PCT (P/N: C53987)
Access Ferritin Calibrators (P/N: 33025)
Access Ferritin (P/N: 33020)
Access OV Monitor Calibrators (P/N: 386358)
Access PCT Calibrators (P/N: C53986)
Access BNP (P/N: 98200)
Access BNP QC (P/N: 98201)
Access BNP Calibrators (P/N: 98202)
Access hsTnI Calibrator (P/N: C26909)
Access Ostase Calibrators (P/N: 37305)
Access Rubella IgG
Access Unconjugated Estriol Calibrators (P/N: C22256)
Access Unconjugated Estriol (P/N: 33570)
Access Unconjugated Estriol (P/N: C22255)
Access Thyroglobulin Antibody II (P/N: C86552)
Access Thyroglobulin Antibody II Calibrators (P/N: A36920)
Access Toxo IgG Calibrators (P/N: A31589)
Access Toxo IgG (P/N: A31588)
Access Toxo IgG QC (P/N: A31590)
Access Progesterone Calibrator S0 (P/N: 33556)
Access Progesterone (P/N: 33550)
Access Progesterone Calibrators (P/N: 33555)
Access Progesterone II (P/N: C78020)
Access Progesterone II Sample Diluent (P/N: C81798)
Access Progesterone II Calibrators (P/N: C78021)
Access Toxo IgG
PerFix NC Kit (Lysing Reagent)
IRIS BODY FLUIDS LYSING REAGENT
AQUIOS Lysing Reagent Kit
Fixative Solution (10X)
OptiLyse C : Lysing Solution
Lysing Solution (10X)
IntraPrep
Reagent 2: Permeabilization
IOTest 3 Fixative
VersaLyse : Lysing Solution
IOTest 3 Lyse
DxH 500 Series Lyse (PN B36846)
Whole Blood Lysing Reagent
COULTER Rinsol Cleaning Agent
DxH Cell Lyse 1L & 5L
AcT 5diff Fix
DxH Retic Pack
IMMUNOPREP REAGENT
DxH diff Pack
AcT 5diff Hgb Lyse
COULTER DxH Cell Lyse
DxH ECO Cell Lyse (5L)
AcT 5diff WBC Lyse
Access Red Blood Cell Folate Lysing Agent
DxH ECO Cell Lyse (1L)
Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG)
iQ Body Fluids Module Key Disc Set (800-3016)
iQ Body Fluids Module Starter Kit (800-3704)
Access Sensitive Estradiol Calibrator S0 (P/N: B97145)
Access Sensitive Estradiol Calibrators (P/N: B84494)
Access C-Peptide Calibrators (P/N: C31860)
Access Syphilis Calibrators (P/N: C80412 MFG-BioRad)
Access EPO Calibrators (P/N: A16365)
Access Estradiol Calibrators (P/N: 33545)
Access Estradiol Calibrators S0 (P/N: 33546)
Access NT-proBNP (P/N: C71977)
Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel DxI Immunoassay System (P/N: A98857 MN MFG)
Access 25(OH) Vitamin D Total for Use on the UniCel DxI Immunoassay System (P/N: A98856 MN and IE MFG)
Access p2PSA QC (P/N: A56934)
DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522 (JPN MFG)
DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63521 (JPN MFG)
DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, C13252 (Chaska MFG)
Access GI Monitor (P/N: 387687)
Access GI Monitor Calibrators (P/N: 387688)
Access Free T4 (P/N: 33880 MN and IE MFG)
Access Folate (P/N: A98032 MN and IE MFG)
Access Ultrasensitive hGH Calibrators (P/N: 33585)
Access Folate Calibrator S0 (P/N: A99250)
Access Folate Calibrators (P/N: A98033)
Access BR Monitor Calibrators (P/N: 387647)
Access Syphilis QC (P/N: C80413 MFG-BioRad)
Access sTFR QC (P/N: B11056 and B11057)
Access Ostase QC (P/N: 37309)
Access 25(OH) Vitamin D Total (A98856 MN and IE MFG)
Access 25(OH) Vitamin D Total (C28646 MN MFG)
Access CK-MB (P/N: 386371 MN and IE MFG)
Access CK-MB Calibrators (P/N: 386372 MN MFG)
Access CK-MB (P/N: D00534)
Active Inhibin A ELISA, Model DSL-10-28100
Access Hybritech Free PSA QC (P/N: 37219)
Access Total ?hCG (5th IS) (P/N: A85264 MN and IE MFG)
Access Total ?hCG (5th IS) (P/N: C28645 MN MFG)
Access Thyroglobulin (P/N: C71762)
Access TSH (3rd IS) Calibrators (P/N: B63285 MN MFG)
Access Thyroglobulin Antibody II (P/N: A32898)
Access Unconjugated Estriol Calibrators (P/N: 33575)
Access Ferritin (P/N: C22490)
Access Hybritech free PSA (P/N: 37210 MN and IE MFG)
Access Hybritech Free PSA Calibrators (P/N: 37215 MN MFG)
Access Hybritech free PSA (P/N: C22846 MN MFG)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Device in the United States for Export Only