Identity
- Trade Name
- ClearChem Diagnostics Inc. Albumin FDA UDI
- Generic Name
- Albumin IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing R1: 4X60mL FDA UDI
- Model / Reference
- ALB1000 FDA UDI
- Description
- In Vitro Diagnostics testing R1: 4X60mL FDA UDI
Identifiers
- Catalog Number
- ALB1000 FDA UDI
- Primary DI / UDI-DI
- 00852169008010 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 240 Milliliter FDA UDI
Category: Albumin IVD, reagent
ClearChem Diagnostics Inc. Albumin by Clearchem Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI ffd786b0-61a4-4351-a3ea-e66c1ea5902b 37 fields · synced May 30, 2026