Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Albumin IVD, reagent FDA UDI
- Device Name
- Albumin Reagent FDA UDI
- Model / Reference
- SA2001 FDA UDI
- Description
- Albumin Reagent FDA UDI
Identifiers
- Catalog Number
- SA2001 FDA UDI
- Primary DI / UDI-DI
- 00857969006136 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Albumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Albumin IVD, reagent
Ace by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, reagent.
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- VITROS — Ortho-Clinical Diagnostics · Class II
- Albumin -BCG method TC-Matrix — TECO DIAGNOSTICS · Class II
- Ricca Chemical Company® — RICCA CHEMICAL COMPANY LLC · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI cf9a1746-c19c-4e51-939d-f77697ae6e1d 36 fields · synced Jun 8, 2026