Identity
- Trade Name
- Creatinine Reagent Set FDA UDI
- Generic Name
- Creatinine IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function. FDA UDI
- Model / Reference
- R1 x 500mL, R2 x 125mL FDA UDI
- Description
- For the quantitative determination of creatinine in serum. For in vitro diagnostic use only. Creatinine assays are most frequently performed to aid in the determination of renal function. FDA UDI
Identifiers
- Catalog Number
- 501-409 FDA UDI
- Primary DI / UDI-DI
- 00812137011961 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Creatinine IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Creatinine IVD, reagent
Creatinine Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- ClearChem Diagnostics Inc. Creatinine (Jaffe) — CLEARCHEM DIAGNOSTICS INC. · Class II
- CREATININE/ ENDPOINT — STERLING DIAGNOSTICS INC
- Alinity — 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
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 17db1303-4daa-4f77-a571-97e6ea798f83 36 fields · synced Jun 6, 2026