BioSign Flu A+B card BSP-510-25-01

GUDID 10743816001478

Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Primary Device ID	10743816001478
NIH Device Record Key	8ec69799-27a5-469c-a628-18d972885c5c
Commercial Distribution Status	In Commercial Distribution
Brand Name	BioSign Flu A+B card
Version Model Number	BSP-510-25-01
Catalog Number	BSP-510-25-01
Company DUNS	362917692
Company Name	PRINCETON BIOMEDITECH CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
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	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	10743816001478 [Primary]

GNX	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Steralize Prior To Use	false
Device Is Sterile	false