Identity
- Trade Name
- CREATININE PAP SL FDA UDI
- Generic Name
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
- Model / Reference
- CRSL-0250 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540214301 FDA UDI
- GMDN Term
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- 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
Yes
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, kit, enzyme spectrophotometry
Creatinine Pap Sl by Vitalscientific — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Creatinine IVD, kit, enzyme spectrophotometry.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- Creatinine Enzymatic — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- Creatinine LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- Creatinine plus ver.2 — Roche Diagnostics Corp. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitalscientific
Sources (2)
- FDA UDI f414fa6e-cd60-4e77-9de6-0e7eb482a2e8 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026