Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, reagent FDA UDI
- Device Name
- Direct Bilirubin Reagent FDA UDI
- Model / Reference
- SA1007 FDA UDI
- Description
- Direct Bilirubin Reagent FDA UDI
Identifiers
- Catalog Number
- SA1007 FDA UDI
- Primary DI / UDI-DI
- 00857969006082 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Conjugated (direct) bilirubin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 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
No
FDA UDI
Category: Conjugated (direct) bilirubin IVD, reagent
Ace by Alfa Wassermann, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conjugated (direct) bilirubin IVD, reagent.
- Alinity — Abbott · Class II
- D BIL — Randox Laboratories, Ltd. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Pointe Direct Bilirubin for BS480 — POINTE SCIENTIFIC, INC. · Class II
- POINTE SCIENTIFIC Bilirubin, Direct — POINTE SCIENTIFIC, INC. · Class II
- ClearChem Diagnostics Inc. Direct Bilirubin — CLEARCHEM DIAGNOSTICS INC. · Class II
- ARCHITECT — Abbott · Class II
- Teco Diagnostics Direct Bilirubin TC-Matrix — TECO DIAGNOSTICS · 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 5071a1fb-1b48-4348-bb3f-e9519b7bec17 36 fields · synced May 30, 2026