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Sign in to claim this brandAlfa Wassermann, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4 Henderson Dr, West Caldwell, NJ, 07006
- Website
- alfawassermannus.com
- —
- —
- [email protected]
- Phone
- 973-852-0158
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000122044
- DUNS Number
- 781990924
Catalogue (80)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alfa Wassermann | E1-3 | FDA UDI | N/A | Active |
| Ace | SA1023 | FDA UDI | Class I | Active |
| Alfa Wassermann | C2-86 | FDA UDI | Class I | Active |
| Ace | RX2011 | FDA UDI | Class II | Active |
| ACE Axcel® | 404200-1 | FDA UDI | Class I | Active |
| Alfa Wassermann | C1-4 | FDA UDI | Class I | Active |
| Ace | RX2002 | FDA UDI | Class II | Active |
| Ace | SA1020 | FDA UDI | N/A | Active |
| Alfa Wassermann | E1-9 | FDA UDI | N/A | Active |
| Ace | SA2038 | FDA UDI | Class I | Active |
| Ace | S3-4 | FDA UDI | Class II | Active |
| Alfa Wassermann | S2-87 | FDA UDI | Class II | Active |
| Ace | S2-76 | FDA UDI | Class II | Active |
| Ace | SA3007 | FDA UDI | Class II | Active |
| Ace | E1-7 | FDA UDI | N/A | Active |
| Ace | SA1025 | FDA UDI | Class I | Active |
| Ace | ACI-35 | FDA UDI | Class II | Active |
| Ace | SA2019 | FDA UDI | Class I | Active |
| Ace | SA2039 | FDA UDI | Class II | Active |
| Ace | SA1053 | FDA UDI | Class II | Active |
| Ace | SA1017 | FDA UDI | Class I | Active |
| S-Test Creatinine (cre) | K080073 | FDA 510(k) | Class II | Active |
| Ace Alt Reagent | K113382 | FDA 510(k) | Class I | Active |
| Ace Hemoglobin A1c Reagent, Model Aci-21, Hemoglobin A1c Calibrators, Model S2-72, Hemoglobin A1c Controls, Model C2-72 | K063306 | FDA 510(k) | Class II | Active |
| Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent | K113436 | FDA 510(k) | Class II | Active |
| Ace -gt Reagent; Ace Lipase Ragent; Ace T4 Reagent | K131515 | FDA 510(k) | Class II | Active |
| Ace Carbon Dioxide(co2-Lc) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent | K113435 | FDA 510(k) | Class II | Active |
| S-Test Lactate Dehydrogenase (ld), Model Rc 0017 | K091544 | FDA 510(k) | Class II | Active |
| S-Test Ldl Cholesterol (ldl), Model Rc0022 | K091333 | FDA 510(k) | Class I | Active |
| S-Test Cholesterol (cho), Model Rc0009, S-Test Hdl Cholesterol (hdl), Model Rc0015, S-Test Triglycerides (tg) | K091413 | FDA 510(k) | Class I | Active |
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 5, 2014 | Z-1529-2014 | — | terminated | Extremely low absorbance readings. |
| Mar 5, 2014 | Z-1530-2014 | — | terminated | Extremely low absorbance readings. |
| Oct 10, 2012 | Z-0743-2013 | — | terminated | Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results. |
| Aug 22, 2008 | Z-0482-2009 | — | terminated | 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. |
| Jan 26, 2006 | Z-0676-06 | — | terminated | Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high. |