Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, reagent FDA UDI
- Device Name
- Creatine Kinase FDA UDI
- Model / Reference
- 7D63-21 FDA UDI
- Description
- Creatine Kinase FDA UDI
Identifiers
- Catalog Number
- 07D6321 FDA UDI
- Primary DI / UDI-DI
- 00380740012878 FDA UDI
- FDA Product Code
- CGS FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Total creatine kinase (CK) IVD, reagent
Architect by Abbott Laboratories, Inc. — 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
- IDG/Sanzay — IDG/SANZAY Corporation · 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
- VITROS — Ortho-Clinical Diagnostics · Class II
- Piccolo MetLyte 8 Panel — ABAXIS, 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
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI aa02f054-a102-45e1-a0fe-1577cfdf4672 36 fields · synced Jun 1, 2026