i-STAT 06P17-04
i-STAT 06P17-04 is a Class I device made by Abbott Point of Care Inc., listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00054749001200), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00054749001200 | Date23 Jun 2023 | StatusListed |
Official records
- AccessGUDID record 00054749001200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- i-STAT
- Generic name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control
- Model / Ref / Catalog
- 06P17-04
- Primary DI / UDI-DI
- 00054749001200
- FDA product code
- JJY
- GMDN term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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