GS

Basic Information

• Brand Name: GS
• Primary DI: 00847865003049
• Version / Model: 32508
• Catalog Number: 32508
• Company Name: Bio-RAD Laboratories, Inc.
• Labeler DUNS: 844766394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-22
• Public Version: 6
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: 9e90f1ee-55b8-4d0b-a417-619341a61554

Device Description

Human Immunodeficiency Virus Type 1 GS HIV-1 Western Blot, (40 Tests)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVW	Kit,Western Blot,Hiv-1	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
48482	HIV1 antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen, using an immunoblot assay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865003049	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			40 Tests

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius