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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 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ace | RX1012 | FDA UDI | Class II | Active |
| Ace | ACI-32 | FDA UDI | Class I | Active |
| Ace | SA2011 | FDA UDI | Class II | Active |
| Ace | S2-71 | FDA UDI | Class II | Active |
| Ace | SA1021 | FDA UDI | N/A | Active |
| Ace | SA1052 | FDA UDI | Class I | Active |
| Ace | SA1022 | FDA UDI | Class II | Active |
| Ace | SA1044 | FDA UDI | Class II | Active |
| Ace | E1-5 | FDA UDI | N/A | Active |
| Alfa Wassermann | 906178 | FDA UDI | Class II | Active |
| Ace | SA2016 | FDA UDI | Class I | Active |
| Ace | SA1028 | FDA UDI | N/A | Active |
| Ace | RX1023 | FDA UDI | Class I | Active |
| Ace | SA1004 | FDA UDI | Class II | Active |
| Ace | C2-85 | FDA UDI | Class I | Active |
| Ace | SA1010 | FDA UDI | Class I | Active |
| Ace | SA1046 | FDA UDI | Class I | Active |
| Ace | SA1014 | FDA UDI | Class II | Active |
| Alfa Wassermann | SA1029 | FDA UDI | Class II | Active |
| Alfa Wassermann | 903394 | FDA UDI | Class II | Active |
| Ace | RX1010 | FDA UDI | Class I | Active |
| ACE Alera® | 402900-1 | FDA UDI | Class I | Active |
| Alfa Wassermann | C2-87 | FDA UDI | Class I | Active |
| Ace | E1-6 | FDA UDI | N/A | Active |
| Alfa Wassermann | S2-86 | FDA UDI | Class II | Active |
| Ace | SA1045 | FDA UDI | Class I | Active |
| Ace | SA3018 | FDA UDI | Class II | Active |
| Ace | RX1025 | FDA UDI | Class I | Active |
| Ace | SA2013 | FDA UDI | Class I | Active |
| Ace | SA2024 | FDA UDI | Class II | Active |
| Ace | SA2002 | FDA UDI | Class II | Active |
| Ace | RX1053 | FDA UDI | Class II | Active |
| Ace | SA1012 | FDA UDI | Class II | Active |
| Alfa Wassermann | S2-85 | FDA UDI | Class II | Active |
| Ace | SA1008 | FDA UDI | Class II | Active |
| Ace | SA2001 | FDA UDI | Class II | Active |
| Ace | E1-8 | FDA UDI | N/A | Active |
| Ace | SA1043 | FDA UDI | Class I | Active |
| Alfa Wassermann | C1-5 | FDA UDI | Class I | Active |
| Alfa Wassermann | 903393 | FDA UDI | Class II | Active |
| Ace | SA1040 | FDA UDI | Class I | Active |
| Ace | SA1007 | FDA UDI | Class II | Active |
| Alfa Wassermann | E1-2 | FDA UDI | N/A | Active |
| Ace | SA1027 | FDA UDI | N/A | Active |
| Ace | RX1026 | FDA UDI | Class I | Active |
| Ace | RX1047 | FDA UDI | Class II | Active |
| Ace | SA1009 | FDA UDI | Class II | Active |
| Alfa Wassermann | S1-33 | FDA UDI | Class II | Active |
| Ace | SA1050 | FDA UDI | Class II | Active |
| Ace | SA1047 | FDA UDI | Class II | Active |
Related Companies
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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. |