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i-STAT

FDA UDI

Class II (US FDA UDI)

by Abbott Point of Care Inc.

Identity

Trade Name
i-STAT FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Device Name
I-STAT TBI PLASMA CARTRIDGE FDA UDI
Model / Reference
04X64-25 FDA UDI
Description
I-STAT TBI PLASMA CARTRIDGE FDA UDI

Identifiers

Primary DI / UDI-DI
10054749005069 FDA UDI
510(k) Number
K201778 FDA UDI
FDA Product Code
QAT FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, point-of-care 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple clinical chemistry analyser IVD, point-of-care

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

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, point-of-care.

Cleared under the same submission

K201778 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 ce285e1a-1c42-4024-bfdf-e7414db957af 36 fields · synced Jun 9, 2026