Identity
- Trade Name
- Sirrus® Albumin LiquiColor® FDA UDI
- Generic Name
- Albumin IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. FDA UDI
- Model / Reference
- S0285-750 FDA UDI
- Description
- For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. FDA UDI
Identifiers
- Catalog Number
- S0285-750 FDA UDI
- Primary DI / UDI-DI
- 00657498001516 FDA UDI
- FDA Product Code
- DCF FDA UDI
- GMDN Term
- Albumin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Albumin IVD, kit, spectrophotometry
Sirrus® Albumin LiquiColor® by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Albumin IVD, kit, spectrophotometry.
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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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 30d74e60-0732-4787-84ae-c90f6527922c 36 fields · synced Jun 8, 2026