FDA Registration
Active
🇺🇸 United States
Fisher Diagnostics
Reg #: 1181121
·
FEI: 1181121
·
Expires 2026
Products
118
Proprietary Names
378
Establishment Types
5
Classifications
118
Registration Details
- Registration Name
- Fisher Diagnostics
- Registration Number
- 1181121
- FEI Number
- 1181121
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8365 VALLEY PIKE
- City
- MIDDLETOWN
- State
- VA
- ZIP
- 22645
- Country
- US
Regulatory Submissions
- 510(k) Number
- K860715
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-11-28 |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2016-11-28 |
| Calibrator, Primary | JIS | Class 2 | Clinical Chemistry | No | 2016-11-28 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2015-04-13 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-01-09 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2013-01-30 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | Class 1 | Immunology | No | 2018-04-10 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Catalytic Methods, Amylase | JFJ | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Biuret (Colorimetric), Total Protein | CEK | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Enzymatic, Carbon-Dioxide | KHS | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Photometric Method, Iron (Non-Heme) | JIY | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Acid, Uric, Uricase (Colorimetric) | KNK | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 1995-09-05 |
| Control, Plasma, Abnormal | GGC | Class 2 | Hematology | No | 2008-01-09 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2008-01-09 |
| Instrument, Coagulation | KQG | Class 2 | Hematology | No | 2008-01-09 |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | Class 1 | Clinical Chemistry | No | 2008-01-09 |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | Class 1 | Clinical Chemistry | No | 1992-12-16 |
| U.V. Spectrometry, Theophylline | LCY | Class 2 | Clinical Toxicology | No | 2008-01-09 |
| System, Fibrinogen Determination | KQJ | Class 2 | Hematology | No | 2008-01-09 |
| Iga, Antigen, Antiserum, Control | CZP | Class 2 | Immunology | No | 2013-01-30 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2013-02-01 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2008-01-09 |
| Colorimetry, Cholinesterase | DIH | Class 1 | Clinical Toxicology | No | 2008-01-09 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2019-03-11 |
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2006-05-17 |
| Drink, Glucose Tolerance | MRV | Class 2 | Clinical Chemistry | No | 2008-02-11 |
| Acid Phosphatase, Naphthyl Phosphate | CKB | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2005-02-24 |
| Photometric Method, Magnesium | JGJ | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-03-22 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-05-03 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | Class 2 | Clinical Chemistry | No | 2019-11-26 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-01-30 |
| Solution, Isotonic | JCE | Class 1 | Pathology | No | 1998-09-10 |
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2008-01-09 |
| Cresolphthalein Complexone, Calcium | CIC | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2008-04-03 |
| Bromcresol Purple Dye-Binding, Albumin | CJW | Class 2 | Clinical Chemistry | No | 2013-01-30 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Acid, Uric, Uricase (U.V.) | CDO | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Enzyme Immunoassay, Theophylline | KLS | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Calibrators, Drug Specific | DLJ | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2017-11-10 |
| Flame Photometry, Lithium | JIH | Class 2 | Clinical Toxicology | No | 2017-11-10 |
| Alpha-1-Lipoprotein, Antigen, Antiserum, Control | DER | Class 2 | Immunology | No | 2013-01-30 |
| Mercuric Thiocyanate, Colorimetry, Chloride | CHJ | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Test, Sickle Cell | GHM | Class 2 | Hematology | No | 2008-01-09 |
| Bromcresol Green Dye-Binding, Albumin | CIX | Class 2 | Clinical Chemistry | No | 2013-01-30 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2013-01-30 |
| Test, Fibrinogen | GIS | Class 2 | Hematology | No | 2008-01-09 |
| Turbidimetric, Total Protein | JGQ | Class 2 | Clinical Chemistry | No | 2013-01-30 |
| Hexokinase, Glucose | CFR | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2008-01-09 |
| Plasma, Coagulation Factor Deficient | GJT | Class 2 | Hematology | No | 2008-01-09 |
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2008-01-09 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2015-01-06 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2015-01-06 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2015-01-06 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2015-01-06 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2008-01-09 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2008-01-09 |
| Counter, Differential Cell | GKZ | Class 2 | Hematology | No | 2013-01-30 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Detergent | JCB | Class 1 | Pathology | No | 2013-01-30 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2006-03-02 |
| Products, Red-Cell Lysing Products | GGK | Class 1 | Hematology | No | 2013-01-30 |
| Stain, Reticulocyte | GJH | Class 1 | Hematology | No | 1997-01-28 |
| Bathophenanthroline, Colorimetry, Iron (Non-Heme) | CFM | Class 1 | Clinical Chemistry | No | 2013-01-30 |
| Test, Equipment, Automated Bloodborne Pathogen | MZA | Class N | Unknown | No | 2013-02-01 |
| Counter, Cell, Automated (Particle Counter) | GKL | Class 2 | Hematology | No | 2013-01-30 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2005-02-24 |
| Transferrin, Antigen, Antiserum, Control | DDG | Class 2 | Immunology | No | 2013-01-30 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | Class 2 | Clinical Chemistry | No | 2008-01-08 |
| Instrument, Coagulation, Automated | GKP | Class 2 | Hematology | No | 2008-01-09 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2015-08-28 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2013-01-30 |
| Diethyldithiocarbamate (Colorimetric), Copper | JKZ | Class 1 | Clinical Chemistry | No | 2008-01-09 |
| Azo Dye, Calcium | CJY | Class 2 | Clinical Chemistry | No | 2015-10-20 |
| Enzymatic Method, Ammonia | JIF | Class 1 | Clinical Chemistry | No | 2008-01-08 |
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2008-01-09 |
| Activated Partial Thromboplastin | GFO | Class 2 | Hematology | No | 2008-01-09 |
| Igg, Antigen, Antiserum, Control | DEW | Class 2 | Immunology | No | 2013-01-30 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2013-09-13 |
| Radioassay, Triiodothyronine Uptake | KHQ | Class 2 | Clinical Chemistry | No | 2007-05-21 |
| Assay, Porphyrin, Spectrophotometry, Lithium | NDW | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Enzyme Immunoassay, Phenobarbital | DLZ | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Enzyme Immunoassay, Carbamazepine | KLT | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens | PMT | Class 2 | Microbiology | No | 2017-07-25 |
| Procalcitonin Assay | PRI | Class 2 | Microbiology | No | 2017-07-25 |
| 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 | 2017-07-25 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | Class 1 | Clinical Chemistry | No | 2008-01-09 |
| Complement C3, Antigen, Antiserum, Control | CZW | Class 2 | Immunology | No | 2013-02-01 |
| Plasma, Control, Normal | GIZ | Class 2 | Hematology | No | 2008-01-09 |
| Haptoglobin, Antigen, Antiserum, Control | DAD | Class 2 | Immunology | No | 2013-01-30 |
| Igm, Antigen, Antiserum, Control | DFT | Class 2 | Immunology | No | 2013-01-30 |
| Enzyme Immunoassay, Diphenylhydantoin | DIP | Class 2 | Clinical Toxicology | No | 2013-01-30 |
| Fluorometric, Cortisol | JFT | Class 2 | Clinical Chemistry | No | 2007-05-21 |
| Lipoprotein, Low-Density, Antigen, Antiserum, Control | DFC | Class 2 | Immunology | No | 2013-01-30 |
Proprietary Names
Microalbumin
Alinity c Microalbumin Calibrators
Alinity c Microalbumin Reagent Kit
Alinity c Microalbumin Controls
AxSYM Probe Cleaning Solution
Alkaline Phosphatase (TRIS)
INR Controls
INR Control Plasmas
Glucose Standard (200mg/dL)
Calcium Standard (10mg/dL)
Phosphorus Standard (5.5mg/dL)
Carbon Dioxide Standard (25mMol/L)
Creatinine Standard (5mg/dL)
Chloride Standard (100mm)
Bicarbonate Standard, 25mEq/L
Magnesium Standard (3.65mg/dL)
Prealbumin
Creatinine
Infinity Creatinine
Buffer pH XXX
Phosphate-Buffered Saline pH 7.4
pH Control Standards
Coagulation Control 3
Coagulation Control Level 3
Thermo Scientific dTIBC Calibrator
Total Protein Reagent
Alinity c Alkaline Phosphatase Reagent Kit
Abbott Clinical Chemistry Alkaline Phosphatase
Thromboscreen 200, Instrument
GGT (Liquid) Reagent 1
Alinity c Gamma-Glutamyl Transferase Reagent Kit
Gamma-Glutamyl Transferase
Abbott Clinical Chemistry GGT
Abbott Clinical Chemistry Triglycerides
Theophylline Standard
Alinity c Cholesterol Reagent Kit
Abbott Clinical Chemistry Cholesterol
Thrombin Time Reagent
Activated Alanine Aminotransferase
Alinity c Activated Alanine Aminotransferase Reagent Kit
Alinity c Immunoglobulin A Reagent Kit
HDL Low Control
HDL High Control
HDL Medium Control
Cholinesterase
Kit Roche Cell CollectionMedium 945 ML
Kit Dispenser for 945 ML RCCM Bottle
Kit Roche Cell Collection Medium 20 ML
Reference Emulsion Fluid
Alinity c Prealbumin Reagent Kit
Kontact Reagent
Kontact APTT Reagent
Olympus Alkaline Phosphatase
Iron Standard
ARCHITECT ANTI-TPO Immunoassay Reagents
Alinity i Anti-TPO Reagent Kit
ARCHITECT Anti-TPO Controls
ARCHITECT Anti-TPO Calibrators
Glucocrush Fruit Punch (50, 75, 100)
Glucocrush Orange (50, 75, 100)
Glucocrush Lemon-Lime (50, 75, 100)
Acid Phosphatase Liquid Stabilizer
Acid Phosphatase
AUTO CELLINE
ISOTON DILUTANTS
1.3% SALINE CS-555
Nerl Blood Bank Saline (20L)
Blood Bank Saline (10L)
ISOTON DILUTANT
Alinity h-series Diluent
Infinity ACE Controls
Alinity c ICT Sample Diluent
Alinity c Activated Aspartate Aminotransferase Reagent Kit
Activated Aspartate Aminotransferase
Iron / UIBC Calibrators
Alinity i Anti-Tg Calibrators
Alinity i Anti-TPO Calibrators
Alinity i Cortisol Calibrators
Alinity i T-Uptake Calibrators
Alinity i BRAHMS PCT Calibrators
Lactate Dehydrogenase
Blood Bank Saline
Nerl Blood Bank Saline
D-Dimer Latex Reagent
D-Dimer Assay Kit
Calcium
Architect MPO Reagent Kit
Alinity c Albumin BCP Reagent Kit
Abbott Clinical Chemistry Albumin BCP
DCA/Microalbumin Creatine Control
Alinity c Triglyceride Reagent Kit
Triglyceride
Enzymatic Creatinine Reagent
Lipid Controls
CEM - ELECTRODE, ION SPECIFIC, POTASSIUM JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM
Alinity c Carbon Dioxide Calibrator
Bilirubin Calibrator
Multiconstituent Calibrator
Alinity c Urine/CSF Protein Calibrator Kit
Alinity c Iron Calibrator Kit
Alinity i Anti-TPO Controls
Carbon Dioxide Calibrator
Chloride
Sicklescreen Assay Kits
Sicklescreen Control Set
Alinity c Albumin BCG Reagent Kit
Cardiac Enzyme Control
Fibrinogen Assay Kit
Fibrinogen Reference Plasma Normal
Fibrinogen Reference Plasma
Imidazole Buffered Saline
IBS
Diluting Fluid
Bovine Thrombin
Barbital Buffered Saline
Urine/CSF Protein
Infinity Glucose Hexokinase
Glucose Hexokinase
Ammonia Standard Set
Infinity BUN/Urea 2 x 125mL
Abnormal Thrombin Time Control
Low Fibrinogen Control
High Fibrinogen Control
Alinity c Lactic Acid Reagent Kit
Lactate Liquid
Lactic Acid
Factor VIII Deficient Plasma, immun
Architect Troponin-I Reagent Kit
Architect Troponin-I Calibrator Kit
Magnesium
Alinity c Magnesium Reagent Kit
Magnesium Arsenazo
Normal Control
Abnormal Control
Clinitek Novus Rinse Additive Kit
Clinitek Novus Calibrator Kit
DiStat D-Dimer Assay Kit
DiStat D-Dimer Control Kit
Infinity Amylase
Infinity Glucose Oxidase
Glucose Oxidase DST
Glucose Oxidase
Glucose Oxidase LSP
Infinity ACE Calibrator
ACE CLINICAL CHEMISTRY SYSTEM
ACE System Diluent
Iron, Liquid
Chromogen Reagent
Calcium CPC
Cell-DYN Emerald Cleaner
Alinity c ICT Serum Calibrator Kit
Alinity c Bilirubin Calibrator Kit
Alinity c Multiconstituent Calibrator Kit
Alinity c Carbon Dioxide Calibrator Kit
Atellica CH Chemistry Calibrator
Urine/CSF Protein Calibrator
Aliniity c Iron Calibrator Kit
Carbon Dioxide Calibrator (Architect)
Multiconstituent Calibrator (Architect)
ICT Serum Calibrator Kit
Bilirubin Calibrator (Architect)
Atellica CH A-LYTE IMT Dilution Check
ARCHITECT STAT CK-MB I
ARCHITECT STAT CK-MB
Alinity c Urine/CSF Protein Reagent Kit
AST (GOT)
AST (DST)
Infinity AST (GOT)
RETICULOCYTE
Reticulocyte Stain
ARCHITECT STAT Myoglobin Controls
ARCHITECT STAT CK-MB Controls
Thromboscreen 400C Instrument
Architect Rubella Control Kit
Architect MPO Control Kit
Alinity i T-Uptake Controls
ARCHITECT B.R.A.H.M.S PCT Controls
Calcium Arsenazo III
Alinity c Total Protein Reagent Kit
Total Protein Reagent Kit
ARCHITECT BRAHMS PCT Calibrators
Alinity c Urea Nitrogen Reagent Kit
Multiple Accessories
95% Dehydrant
Isopropanol
R40132 Ethanol (95%)
70% Dehydrant
R40106 TB Decolorizer (Acid Alcohol) 3%
R2470110 Ethanol (70%)
Methanol
Flex 95
Cell Wash Solution I/NaOH-D
60% Dehydrant
CleanCell M 2x2L,
Para-Release Spray
Isopropyl Alcohol
Flex 100
100% Dehydrant
R40206 TB Decolorizer (3%)
R40134 Acid Ethanol (90%),
Methyl Alcohol
Flex 80
Acetone
Base Mold Release
Syntri Safeguard, Flex 100
Fast Flex Kit 1
Ethyl Alcohol
80% Dehydrant
Cell Wash Solution I/NaOH-D 2x1, 8L
Syntri Safeguard, Isopropyl Alcohol
Fast Flex Kit 2
Reagent Alcohol
Syntri Safeguard, Dehydrant 100%
Clean Cell M 2x2L
HE600 Cleaning Kit
Alinity c Transferrin Reagent Kit
Abbott Clinical Chemistry Transferrin
Alinity c Creatinine Reagent Kit
Olympus CK-NAC
Alinity c Lactate Dehydrogenase Reagent Kit
Fibrinogen Reagent with Kaolin
Alinity c Phosphorus Reagent Kit
Phosphorus
Buffer 6.838
Wash G/L Zero Reagent
Cal G/L Reagent
Cleaning Solution 1 and Cleaning Solution 2 (C1/C2)
Buffer 7.382 (7.3/CO-ox Zero Buffer)
Infinity Uric Acid
Uric Acid
Glycine Buffered Saline
FDP Sample Collection Tubes
FDP Positive and Negative Control S
FDP Assay Kit
FDP Latex Reagent
Clinitek Atlas Rinse Additive
Clinitek Atlas Calibration Kit
Clinitek Atlas Calibrator #4 (Clarity)
Alkaline Phosphatase IFCC
Alkaline Phosphatase PNPP
Alkaline Phosphatase (AMP)
Alkaline Phosphatase (AMP) Buffer
ALP
Copper 2-part Liquid
ICT Reference Solution
ICT Serum Calibrator
Clinical Chemistry Alkaline Wash
Clinical Chemistry Acid Wash
Olympus Albumin
CALCIUM
Alinity c Calcium Reagent Kit
Coagulation Control Level 2
Coagulation Control 2
Calibrator Set, High / Low
DataCal Calibrator Reference Serum
Infinity Ammonia Liquid Stable Reagent
Thromboplastin-DS Reagent
APTT-XL Reagent
Calcium Chloride, 020M
Calcium Chloride, 025M
APTT-LS Reagent
Albumin
Hitachi Albumin
Albumin BCP
ARCHITECT Acid Wash
ARCHITECT Alkaline Wash
Alinity c Immunoglobulin G Reagent Kit
Contour High Control
Bayer Contour TS
Countour Normal Control
Contour Low Control
Contour Normal Bulk, Contour Normal Single Control
125I T3 UPTAKE RADIOASSAY KIT
ARCHITECT T-Uptake
DRI T-Uptake (EIA Assay)
Alinity i T-Uptake Reagent Kit
DRI T-Uptake Calibrator Kit
CEDIA T-Uptake Assay
Microprotein
Microprotein Standard
ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37, 6P22-25, 6P22-35)
Alinity i BRAHMS PCT Reagent Kit (LN 01R1821)
ARCHITECT BRAHMS PCT Controls (LN 6P22-10)
ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01)
Alinity c Uric Acid Reagent Kit
AcroMetrix Negative Control
AcroMetrix HBV High Control
AcroMetrix HIV-1 Low Control
Acrometrix EV Low Control
Acrometrix BB NAT HBV Positive Control
AcroMetrix HCV High Control
Alinity i Anti-Tg Controls
AcroMetrix HIV-1 High Control
AcroMetrix HIV-1 Mid Control
Alinity i BRAHMS PCT Controls
AcroMetrix HBV Low Control
AcroMetrix BKV Low Control
AcroMetrix HCV Mid Control
MAS PTH Control
AcroMetrix HCV Low Control
AcroMetrix HBV Mid Control
AcroMetrix BKV High Control
Alinity c Cannabinoids Control 2 Kit
MAS Diabetes Control
Acrometrix EBV High Plasma Control
MAS Bilirubin Control
Acrometrix EV Negative Control
DRI THC Urine Controls
Acrometrix EBV Low Plasma Control
MAS CardioImmune UL
Alinity c Cannabinoids Control 1 Kit
MAS SARS-CoV-2 IgG Positive Control
MAS SARS-CoV-2 Negative Control
MAS Diabetes Max Control
Alinity Phosphorus Reagent Kit
Olympus GGT
GGT, Soluble Substrate
GAMMA GT - GLUPA C
GAMMA GT - SS
Albumin Standard (4g/dL)
Total Protein Standard (8g/dL)
LDH-L
LDH-P
U.C.R.P.
A.C.R.P.
Contour Next Level 1
Contour Next Level 2
Alinity c Aspartate Aminotransferase Reagent Kit
Aspartate Aminotransferase
FisherBrand Sun-Dex (50,75,100)
FisherBrand Fruit Punch (50,75,100)
Trutol GTTB Fruit Punch (50,75,100)
FisherBrand Limeondex (50,75,100)
Trutol GTTB Lemon-Lime (50,75,100)
Trutol GTTB Orange (50,75,100)
GGT Enzyme Reagent
UIBC Reagent Ferene Method
Iron / UIBC
UIBC Saturating Standard
UIBC FerroZine Method
Coagulation Control Level 1
Coagulation Control Plasma Level 1
Coagulation Controls
Lithium Bulk Liquid
Lithium Standard
Infinity Lithium, Beckman SYNCHRON
Olympus Lithium
Infinity Lithium Reagent for Olympus® Analyzers
Infinity Lithium (Li) Reagent for Beckman Coulter SYNCHRON Systems
Infinity Lithium Standard
Infinity Lithium Liquid Stable Reagent
Infinity Lithium
Infinity Lithium Liquid Reagent
Direct Bilirubin
Alinity c-series Acid Wash
Alinity c-series Acid Probe Wash
Alinity c-series ICT Reference Solution
Alinity c-series Alkaline Wash
High
Low
HIGH
ARCHITECT T-UPTAKE CONTROLS
,LOW
ARCHITECT T-UPTAKE CALIBRATORS
Infinity AST (GPT)
Infinity ALT (GPT)
ARCHITECT Anti-TG Controls
ARCHITECT Anti-TG Reagents
Alinity i Anti-Tg Reagent Kit
ARCHITECT ANTI-TG REAGENT
ARCHITECT Anti-TG Calibrators
ARCHITECT CORTISOL ASSAY
Alinity i Cortisol Reagent Kit
Amylase EPS-G7
Amylase
Amylase LSP
TRIGLYCERIDE,INFINITY,2X125 ML
Cholesterol
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device