Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, reagent FDA UDI
- Device Name
- Creatinine reagent is used for the quantitative determination of creatinine in human serum. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Creatinine reagent is used for the quantitative determination of creatinine in human serum. FDA UDI
Identifiers
- Catalog Number
- C181 FDA UDI
- Primary DI / UDI-DI
- 00850053916106 FDA UDI
- 510(k) Number
- K880629 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Total creatine kinase (CK) 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
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
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDITotal Volume — 120 Milliliter FDA UDITotal Volume — 240 Milliliter FDA UDITotal Volume — 250 Milliliter FDA UDITotal Volume — 480 Milliliter FDA UDITotal Volume — 1 Liter FDA UDI
Category: Total creatine kinase (CK) IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total creatine kinase (CK) IVD, reagent.
- Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set — TECO DIAGNOSTICS · Class II
- ARCHITECT — Abbott · Class II
- ClearChem Diagnostics Inc. Creatine Kinase (CK) — CLEARCHEM DIAGNOSTICS INC. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC Matrix — TECO DIAGNOSTICS · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Piccolo MetLyte 8 Panel — ABAXIS, INC. · Class II
Cleared under the same submission
K880629 also covers:
- Teco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent Set — TECO DIAGNOSTICS
- Teco Diagnostics Creatinine (Kinetic) Reagent Kit TC-MATRIX-240/480 — TECO DIAGNOSTICS
- Teco Diagnostics Creatinine (Kinetic) Reagent Set — TECO DIAGNOSTICS
- Teco Diagnostics Creatinine Reagent Set (Direct Endpoint Procedure) — TECO DIAGNOSTICS
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
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI c523b16c-51c1-4e11-aad4-c49751f2d57a 37 fields · synced Jun 8, 2026