Identity
- Trade Name
- CK-MB AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 2975-300 FDA UDI
Identifiers
- Catalog Number
- 2975-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022345 FDA UDI
- FDA Product Code
- JHY FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CK-MB AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay.
- ADVIA Centaur® CKMB — Siemens Healthcare Diagnostics · Class II
- Atellica IM CKMB — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Elecsys CK-MB — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM CKMB — Siemens Healthcare Diagnostics · Class II
- Elecsys CKMB STAT Immunoassay — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland 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
- Monobind, Inc.
Sources (1)
- FDA UDI fc31e757-fbbd-4a36-93f5-ee0eec6e56d8 36 fields · synced Jun 6, 2026