Identity
- Trade Name
- CREATININE-S Assay FDA UDI
- Generic Name
- Creatinine IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 221-50 FDA UDI
Identifiers
- Catalog Number
- 221-50 FDA UDI
- Primary DI / UDI-DI
- 00628063400416 FDA UDI
- 510(k) Number
- K000055 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Creatinine IVD, kit, 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
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, spectrophotometry
CREATININE-S Assay by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatinine IVD, kit, spectrophotometry.
- Dimension Vista® Flex® reagent cartridge ECREA — Siemens Healthcare Diagnostics · Class II
- Creatinine Jaff method — Roche Diagnostics Corp. · Class II
- Yumizen C1200 Creatinine Jaffé — Horiba Abx · Class II
- Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set — Carolina Liquid Chemistries Corp. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- CREATININE (CREA) — Randox Laboratories, Ltd. · Class II
- Creatinine Jaff Gen2 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K000055 also covers:
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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 05ab7b2d-9344-4f3f-8a31-d78b331e760a 34 fields · synced Jun 9, 2026