K-CHECK B1555

GUDID 00860009154001

Acetone IVD, reagent

Primary Device ID	00860009154001
NIH Device Record Key	f071a292-9c7d-49e6-bd67-77f8d698dae2
Commercial Distribution Status	In Commercial Distribution
Brand Name	K-CHECK
Version Model Number	1
Catalog Number	B1555
Company DUNS	060975106
Company Name	Biorex Labs LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00860009154001 [Primary]

JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)

Steralize Prior To Use	false
Device Is Sterile	false

00860009154001 - K-CHECK	2022-12-12The 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.
00860009154001 - K-CHECK	2022-12-12 The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-qu
00860009154018 - DIAZO-CHEK	2022-12-12 The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent str
00860009154025 - K-CHECK CONTROLS	2022-12-12 The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy an

Mark Image Registration \| Serial	Company Trademark Application Date
K-CHECK 86828189 5002376 Live/Registered	Biorex Labs LLC 2015-11-21