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K-Check

FDA UDI

Class I (US FDA UDI)

by Biorex Labs LLC

Identity

Trade Name
K-CHECK FDA UDI
Generic Name
Acetone IVD, reagent FDA UDI
Device Name
The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually. FDA UDI
Model / Reference
1 FDA UDI
Description
The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-quantitative presence of two Ketone bodies i.e. acetone and acetoacetic acid in Urine, Serum, Plasma or Whole blood. The test results are read visually. FDA UDI

Identifiers

Catalog Number
B1555 FDA UDI
Primary DI / UDI-DI
00860009154001 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Acetone IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Acetone IVD, reagent

K-Check by Biorex Labs LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acetone IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biorex Labs LLC

Sources (1)

  • FDA UDI f071a292-9c7d-49e6-bd67-77f8d698dae2 36 fields · synced May 30, 2026