FDA.reportPublic FDA data

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

Primary DI
07290015003759
Brand
Alere Determine HIV-1/2 Ag/Ab Combo Controls
Company
Orgenics Ltd
Model
Alere Determine HIV-1/2 Ag/Ab Combo Cont
Catalog number
7D2628
Device description
ContentsHIV-1 Reactive Control, 1.5 mLHIV-2 Reactive Control, 1.5 mLP24 Antigen Control, 1.5 mLHIV Nonreactive Control, 1.5 mL
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015003759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015003759072900150037597290015003759

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antigen/antibody IVD, controlA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877)866-9335ts.scr@alere.com

Regulatory Flags#

DUNS number
600022628
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015003735Alere Determine HIV-1/2 Ag/Ab ComboAlere Determine HIV-1/2 Ag/Ab Combo7D26482014-09-24
07290015003742Alere Determine HIV-1/2 Ag/Ab ComboAlere Determine HIV-1/2 Ag/Ab Combo7D26492014-09-24