K-CHECK CONTROLS B1777

GUDID 00860009154025

Acetone IVD, control

Primary Device ID	00860009154025
NIH Device Record Key	3c08d985-5e2e-4197-8bc9-17d3ff57da6c
Commercial Distribution Status	In Commercial Distribution
Brand Name	K-CHECK CONTROLS
Version Model Number	1
Catalog Number	B1777
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

Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)
Special Storage Condition, Specify	Between 0 and 0 *Refrigerate between 2-10 degrees Celsius (°C)

Device Issuing Agency	Device ID
GS1	00860009154025 [Primary]

JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

Steralize Prior To Use	false
Device Is Sterile	false

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	2022-12-12The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.
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