Identity
- Trade Name
- i-STAT hs-TnI cartridge FDA UDI
- Generic Name
- Troponin I IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- i-STAT hs-TnI cartridge FDA UDI
- Model / Reference
- 09P81-25 FDA UDI
- Description
- i-STAT hs-TnI cartridge FDA UDI
Identifiers
- Catalog Number
- 09P81-25 FDA UDI
- Primary DI / UDI-DI
- 10054749003058 FDA UDI
- 510(k) Number
- K240984 FDA UDI
- FDA Product Code
- MMI FDA UDI
- GMDN Term
- Troponin I IVD, kit, enzyme immunoassay (EIA) 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Troponin I IVD, kit, enzyme immunoassay (EIA)
i-STAT hs-TnI cartridge by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Troponin I IVD, kit, enzyme immunoassay (EIA).
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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 Point of Care Inc.
Sources (1)
- FDA UDI 70c2f289-4e05-47ca-9deb-3a68848bda07 37 fields · synced Jun 9, 2026