Identity
- Trade Name
- Glycated Serum Protein Bi-Level Control Set FDA UDI
- Generic Name
- Fructosamine IVD, control FDA UDI
- Device Name
- Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). FDA UDI
- Model / Reference
- 2370-401 FDA UDI
- Description
- Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). FDA UDI
Identifiers
- Catalog Number
- 2370-401 FDA UDI
- Primary DI / UDI-DI
- 00657498000861 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Fructosamine IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Glycated Serum Protein Bi-Level Control Set by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 5d32ebae-81d0-4722-a2aa-710b95b9914a 37 fields · synced Jun 6, 2026