Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control FDA UDI
- Device Name
- Alinity i STAT CK-MB Controls FDA UDI
- Model / Reference
- 04V3810 FDA UDI
- Description
- Alinity i STAT CK-MB Controls FDA UDI
Identifiers
- Catalog Number
- 04V3810 FDA UDI
- Primary DI / UDI-DI
- 00380740165505 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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
No
FDA UDI
Category: Creatine kinase myocardial isoenzyme (CKMB) IVD, control
Alinity by Abbott Ireland Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, control.
- ADVIA Centaur® CKMB MCM — Siemens Healthcare Diagnostics · Class II
- i-STAT — Abbott Point of Care Inc. · Class I
- POINTE SCIENTIFIC CK-MB Controls — POINTE SCIENTIFIC, INC. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- CK-MB CONTROL — Randox Laboratories, Ltd. · Class II
- Atellica IM CKMB MCM — Siemens Healthcare Diagnostics · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI d50a03dd-4fb6-4891-941a-daf6d3182b96 36 fields · synced Jun 8, 2026