Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2247288

FEI Number

1000122044

Entity Name

ALFA WASSERMANN

City/State/Country

West Caldwell, NJ, US

Establishment Address

4 Henderson Dr, West Caldwell, NJ 07006, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Alfa Wassermann Diagnostic Technologies, LLC (Owner Number: 10028192)

Owner / Operator Contact Address

4 Henderson Drive, West Caldwell, NJ 07006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131975

PMA Number

N/A

All Registered Proprietary Names

ACE Ferritin Reagent ACE T4 Reagent ACE CEDIA TUP Reagent ACE HbA1c Reagent LDL-C Calibrator ACE LDL-C Reagent LDL Cholesterol Controls LDL-C Controls ACE HDL-C Reagent (plasma) ACE Triglycerides Reagent (plasma) ACE LDL-C Reagent (plasma) ACE Cholesterol Reagent (plasma) ACE Alera Clinical Chemistry System ACE Glucose Reagent ACE Ion Selective Electrode (ISE) Module ACE AST Reagent ACE Amylase Reagent ACE ALT Reagent ACE Alkaline Phosphatase Reagent ACE Total Bilirubin Reagent ACE Carbon Dioxide (CO2-LC) Reagent ACE Magnesium Reagent ACE Direct Bilirubin Reagent ACE Direct Biliubin Reagent ACE Total Bilirubin Reagent ACE Magnesium Reagent ACE Carbon Dioxide Reagent ACE Direct Total Iron-Binding Capacity (TIBC) Reagent ACE Iron Reagent ACE Lipase Reagent ACE Creatinine Reagent (urine) ACE Urine Standard ACE Urea Nitrogen Reagent (urine) ACE Inorganic Phosphorus U.V. Reagent (urine) ACE Calcium-Arsenazo Reagent (urine) ACE Magnesium Reagent ACE HDL-C Reagent (Axcel, plasma) ACE Cholesterol Reagent (Axcel, plasma) ACE LDL-C Reagent (Axcel, plasma) ACE Triglycerides Reagent (Axcel, plasma) Level 1 & Level 2 Controls ACE -GT Reagent ACE T4 Reagent ACE Lipase Ragent ACE Albumin Reagent ACE Total Protein Reagent ACE Phosphorus U.V. Reagent ACE Calcium-Arsenazo Reagent ACE CK Reagent ACE BUN/Urea Reagent ACE Creatinine Reagent ACE Uric Acid Reagent ACE Axcel Clinical Chemistry System ACE Total Iron Reagent ACE LDH-L Reagent ACE Direct Total Iron-Binding Capacity (TIBC) Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2013-01-18
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2013-01-18
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2013-01-18
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-01-18
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2009-01-27
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2009-01-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-01-27
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2013-01-18
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2013-01-18
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2013-01-18
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2013-01-18
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-12-17
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-12-17
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-12-17
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-12-17
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-12-17
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2013-12-17
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2013-12-17
CIJ	Saccharogenic, Amylase	Clinical Chemistry	Class 2	862.1070	2013-12-17
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2013-12-17
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2013-01-18
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-01-18
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-01-18
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2013-12-17
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-12-17
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-12-17
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-01-18
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-01-18
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2013-01-18
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-01-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-01-18
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-01-18
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-01-18
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2013-01-18
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-01-18
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2013-01-18
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2013-01-18
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2013-01-18
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2013-01-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-01-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-01-27
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-01-27
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2013-12-17
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2013-12-17
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2013-12-17
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2013-01-18
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2013-01-18
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-01-18
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2013-01-18
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2013-01-18
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-01-18
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-01-18
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2013-01-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-11-28
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-11-28
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-11-28
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-11-28
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-11-28
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2013-12-17
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2013-12-17
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2013-12-17

Official Correspondent

Allan Gennis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alfa Wassermann Diagnostic Technologies, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K941042	Microgenics Corp.	CEDIA T4 MAB ASSAY	1994-04-26
K082638	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL	2009-02-26
K830580	Iagnon Corp.	DIAGNON FERRITIN 125 I RIA KIT	1983-05-05
K100538	Roche Diagnostics	TINA-QUANT FERRITIN GEN. 4	2010-06-22
K920820	Helena Laboratories	MODIFICATION COLUMNMATE	1992-08-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0128-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)
Z-0129-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)
Z-0130-2015	Siemens Healthcare Diagnostics, Inc	2	ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
Z-0017-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2247288. Last updated year: 2026. Please use registration number 2247288 when referencing this establishment in official correspondence.