CalCheck Androstenedione 07679874190

GUDID 07613336169520

Androstenedione IVD, control

Primary Device ID	07613336169520
NIH Device Record Key	5b19ee61-6d5d-4a04-8898-ceb869d3ff6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	CalCheck Androstenedione
Version Model Number	07679874190
Catalog Number	07679874190
Company DUNS	315028860
Company Name	Roche Diagnostics GmbH
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	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature

Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07613336169520 [Primary]

JJX	Single (specified) analyte controls (assayed and unassayed)

Steralize Prior To Use	false
Device Is Sterile	false