Data / Medical devices / United States / Alfa Wassermann
Alfa Wassermann: FDA-registered device maker in West Caldwell, NJ, United States, 23 510(k) clearances
Alfa Wassermann is registered with the FDA (registration 2247288) in West Caldwell, NJ, United States. It lists 37 device types. The FDA files 23 510(k) clearances under its listings, the newest dated October 2, 2013. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2247288
- FEI number
- 1000122044
- Address
- 4 Henderson Dr, West Caldwell, NJ, United States, 07006
- Owner or operator
- Diazyme Laboratories, Inc. (10028192)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 27, 2009
- Registered through
- 2026
- Brand names listed
- ACE -GT Reagent, ACE ALT Reagent, ACE AST Reagent, ACE Albumin Reagent, ACE Alera Clinical Chemistry System, ACE Alkaline Phosphatase Reagent, ACE Amylase Reagent, ACE Axcel Clinical Chemistry System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Uric, Uricase (Colorimetric) | KNK | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Azo Dye, Calcium | CJY | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Biuret (Colorimetric), Total Protein | CEK | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bromcresol Green Dye-Binding, Albumin | CIX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Colorimetric Method, Gamma-Glutamyl Transpeptidase | JPZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Diazo Colorimetry, Bilirubin | CIG | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Enzymatic, Carbon-Dioxide | KHS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ferritin, Antigen, Antiserum, Control | DBF | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hexokinase, Glucose | CFR | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | CDT | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Photometric Method, Iron (Non-Heme) | JIY | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Photometric Method, Magnesium | JGJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Radioassay, Triiodothyronine Uptake | KHQ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Saccharogenic, Amylase | CIJ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Test, Low Density, Lipoprotein | MRR | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Urease, Photometric, Urea Nitrogen | CDN | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2013 | K131975 | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT | CFJ | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| August 19, 2013 | K131488 | ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT | CIX | Substantially Equivalent | Alfa Wassermann Diagnostics Technologies, LLC | accessdata.fda.gov |
| August 15, 2013 | K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT | CJE | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, LLC | accessdata.fda.gov |
| August 14, 2013 | K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | KLI | Substantially Equivalent | Alfa Wassermann | accessdata.fda.gov |
| May 21, 2013 | K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | CDN | Substantially Equivalent | Alfa Wassermann Diagnostics Technologies, LLC | accessdata.fda.gov |
| May 2, 2013 | K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | KHS | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| April 23, 2013 | K123018 | ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE | CFR | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| October 5, 2012 | K122757 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | CHH | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| August 27, 2012 | K122302 | ACE MAGNESIUM REGENT | JGJ | Substantially Equivalent | Alfa Wassermann Diagnostics Technologies, LLC | accessdata.fda.gov |
| August 10, 2012 | K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | CDN | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| August 6, 2012 | K113437 | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT | LCP | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| July 19, 2012 | K113382 | ACE ALT REAGENT | CKA | Substantially Equivalent | Alfa Wassermann | accessdata.fda.gov |
| July 13, 2012 | K113374 | ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT | CIX | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| July 12, 2012 | K113436 | ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT | CJE | Substantially Equivalent | Alfa Wassermann | accessdata.fda.gov |
| July 3, 2012 | K113262 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT | CHH | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| July 2, 2012 | K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | KHS | Substantially Equivalent | Alfa Wassermann | accessdata.fda.gov |
| June 1, 2012 | K113438 | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | JMO | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| May 17, 2012 | K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | JJE | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| March 29, 2012 | K112538 | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT | CHH | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| September 8, 2011 | K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | CDN | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. | accessdata.fda.gov |
| July 13, 1999 | K991733 | ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS | MRR | Substantially Equivalent | Schiapparelli Biosystems, Inc. | accessdata.fda.gov |
| June 10, 1998 | K981377 | ACE T4 REAGENT T4 CALIBRATORS | KLI | Substantially Equivalent | Schiapparelli Biosystems, Inc. | accessdata.fda.gov |
| August 23, 1993 | K930104 | ACE CLINICAL CHEMISTRY SYSTEM | JIX | Substantially Equivalent | Schiapparelli Biosystems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 5, 2014 | 67897 | Class II | Terminated | Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This | Extremely low absorbance readings. | accessdata.fda.gov |
| October 10, 2012 | 63866 | Class II | Terminated | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common n | Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. | accessdata.fda.gov |
| August 22, 2008 | 49563 | Not yet classified | Terminated | ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. | Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems. | accessdata.fda.gov |
| January 26, 2006 | 34687 | Not yet classified | Terminated | Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control. | Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high. | accessdata.fda.gov |
Compare with other makers
- All makers of Enzymatic Esterase--Oxidase, Cholesterol
- All makers of System, Test, Low Density, Lipoprotein
- All makers of Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- All makers of Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- All makers of Calibrator, Primary
- All makers of Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Updated April 30, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.