FDA.report

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
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
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290015003759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290015003759072900150037597290015003759

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
(877)866-9335ts.scr@alere.com

Regulatory Flags

DUNS number
600022628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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