Identity
- Trade Name
- i-STAT FDA UDI
- Generic Name
- Multiple traumatic brain injury marker IVD, control FDA UDI
- Device Name
- I-STAT TBI Control L2 FDA UDI
- Model / Reference
- 06P17-26 FDA UDI
- Description
- I-STAT TBI Control L2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00054749004973 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple traumatic brain injury marker 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple traumatic brain injury marker IVD, control
i-STAT by Abbott Point of Care Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Abbott Point of Care Inc.
Sources (1)
- FDA UDI 93f6d95b-029d-40ac-9a2a-cab293561c8b 35 fields · synced Jun 9, 2026