FDA.reportPublic FDA data

Avioq HIV-I Microelisa System

Primary DI
00853214004148
Brand
Avioq HIV-I Microelisa System
Company
AVIOQ, Inc.
Model
100960
Catalog number
100960
Device description
The Avioq HIV-1 Microelisa System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with OraSure®.HIV-1 Oral Specimen Collection Device.
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853214004148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853214004148008532140041488532140041480853214004148

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 antibody IVD, kit, enzyme immunoassay (EIA)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 enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
919-314-5535infor@avioq.com

Regulatory Flags#

DUNS number
195645259
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
00853214004223VioOne™ HIV Profile™ Supplemental Assay7000247000242024-05-21
00853214004018Avioq HTLV-I/II Microelisa System2001922001922023-05-12
00853214004025Avioq HTLV-I/II Microelisa System2005762005762023-05-12
00853214004032Avioq HTLV-I/II Microelisa System2096002096002023-05-12
00853214004001VioOne™ HIV Profile™ Supplemental Assay4000244000242022-10-18
00853214004070Avioq HTLV-I/II Microelisa System5001925001922014-09-24
00853214004087Avioq HTLV-I/II Microelisa System5005765005762014-09-24
00853214004094Avioq HTLV-I/II Microelisa System5096005096002014-09-24
00853214004131Avioq HIV-I Microelisa System1003841003842014-09-24
00853214004155Avioq HIV-I Microelisa System1096001096002014-09-24