Alere Determine HIV-1/2 Ag/Ab Combo Controls

Basic Information

• Brand Name: Alere Determine HIV-1/2 Ag/Ab Combo Controls
• Primary DI: 07290015003759
• Version / Model: Alere Determine HIV-1/2 Ag/Ab Combo Cont
• Catalog Number: 7D2628
• Company Name: Orgenics Ltd
• Labeler DUNS: 600022628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d433d2b3-af8a-44c7-a039-d7c6c5b4f5be

Device Description

Contents HIV-1 Reactive Control, 1.5 mL HIV-2 Reactive Control, 1.5 mL P24 Antigen Control, 1.5 mL HIV Nonreactive Control, 1.5 mL

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

GMDN Terms

Code	Name	Definition	Implantable	Status
48449	HIV1/HIV2 antigen/antibody IVD, control	A material which is used to verify the performance of an assay intended to be 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	07290015003759	GS1

Customer Contacts

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

Storage Conditions

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