Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- CREATININE LIQUID (2x 125mL + 1x 3mL Standard) FDA UDI
- Model / Reference
- DG-CRE2-125 FDA UDI
- Description
- CREATININE LIQUID (2x 125mL + 1x 3mL Standard) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021439 FDA UDI
- 510(k) Number
- K003247 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Creatinine IVD, kit, enzyme spectrophotometry 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Creatinine IVD, kit, enzyme spectrophotometry
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatinine IVD, kit, enzyme spectrophotometry.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · 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 PAP SL — VITALSCIENTIFIC
- Creatinine plus ver.2 — Roche Diagnostics Corp. · Class II
- Creatinine LiquiColor® — STANBIO LABORATORY, L.P. · Class II
Cleared under the same submission
K003247 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI fe197d44-918e-4b29-b6b4-11fa22dedc91 36 fields · synced May 31, 2026