Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
- Device Name
- ARCHITECT STAT CK-MB Calibrators FDA UDI
- Model / Reference
- 2K42-01 FDA UDI
- Description
- ARCHITECT STAT CK-MB Calibrators FDA UDI
Identifiers
- Catalog Number
- 02K4201 FDA UDI
- Primary DI / UDI-DI
- 00380740003227 FDA UDI
- FDA Product Code
- JIS FDA UDIJHX FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1215 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Architect by Abbott Ireland Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CalSet CK-MB — Roche Diagnostics Corp. · Class II
- Elecsys CKMB CalSet — Roche Diagnostics Corp. · Class I
- Dimension® MMB Calibrator — Siemens Healthcare Diagnostics · 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 Ireland Diagnostics
Sources (1)
- FDA UDI f2dbb917-3bba-472f-bfd6-2a9732cbb1e9 36 fields · synced Jun 6, 2026