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i-STAT TBI cartridge

FDA UDI

Class II (US FDA UDI)

by Abbott Point of Care Inc.

Identity

Trade Name
i-STAT TBI cartridge FDA UDI
Generic Name
Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical FDA UDI
Device Name
i-STAT TBI cartridge FDA UDI
Model / Reference
03S09-25 FDA UDI
Description
i-STAT TBI cartridge FDA UDI

Identifiers

Catalog Number
03S09-25 FDA UDI
Primary DI / UDI-DI
00054749005772 FDA UDI
510(k) Number
K234143 FDA UDI
FDA Product Code
QAT FDA UDI
GMDN Term
Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5830 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

Yes

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: Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical

i-STAT TBI cartridge by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple traumatic brain injury marker IVD, kit, rapid non-ICT electrochemical immunoassay, clinical.

Cleared under the same submission

K234143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Point of Care Inc.

Sources (1)

  • FDA UDI 67b4fc66-b3c7-4d91-ba82-eaf6967cb54c 37 fields · synced Jun 9, 2026