K-CHECK B1555

GUDID 00860009154001

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.

Biorex Labs LLC

Acetone IVD, reagent
Primary Device ID00860009154001
NIH Device Record Keyf071a292-9c7d-49e6-bd67-77f8d698dae2
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-CHECK
Version Model Number1
Catalog NumberB1555
Company DUNS060975106
Company NameBiorex Labs LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com
Phone440-824-3000
Emailinfo@biorexlabs.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009154001 [Primary]

FDA Product Code

JINNitroprusside, Ketones (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-12
Device Publish Date2022-12-02

Devices Manufactured by Biorex Labs LLC

00860009154001 - K-CHECK2022-12-12The 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-CHECK2022-12-12 The K-Check tablet is a chromogenic reagent to be used by trained laboratory professionals to determine the qualitative /semi-qu
00860009154018 - DIAZO-CHEK2022-12-12 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 CONTROLS2022-12-12 The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy an

Trademark Results [K-CHECK]

Mark Image

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

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