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i-STAT

FDA UDI

Class I (US FDA UDI)

by Abbott Point of Care Inc.

Identity

Trade Name
i-STAT FDA UDI
Generic Name
Human chorionic gonadotropin beta-core fragment IVD, control FDA UDI
Device Name
i-STAT total B-hCG Control Level 3 FDA UDI
Model / Reference
02R29-03 FDA UDI
Description
i-STAT total B-hCG Control Level 3 FDA UDI

Identifiers

Catalog Number
02R29-03 FDA UDI
Primary DI / UDI-DI
00054749002573 FDA UDI
510(k) Number
K121237 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Human chorionic gonadotropin beta-core fragment 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

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: Human chorionic gonadotropin beta-core fragment IVD, control

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

Similar devices

Also classified as Human chorionic gonadotropin beta-core fragment IVD, control.

Cleared under the same submission

K121237 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 b52b38ca-2691-4ce4-bfa7-326868daebf2 37 fields · synced Jun 9, 2026