GS

Basic Information

• Brand Name: GS
• Primary DI: 03610522110209
• Version / Model: 12009798
• Catalog Number: 12009798
• Company Name: Bio-RAD Laboratories, Inc.
• Labeler DUNS: 844766394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-20
• Public Version: 3
• Public Version Date: 2020-01-23
• Public Version Status: Update
• Public Device Record Key: e1b483fb-34d3-44d6-8830-a0cd60f8c900

Device Description

Conjugate 2, GS HIV Combo Ag/Ab, 12 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
MZF	Test, HIV detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48450	HIV1/HIV2 antigen/antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610522110209	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BP100064	18

Device Sizes

Type	Value	Unit	Text
Total Volume	12	Milliliter

Storage Conditions

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