FDA.reportPublic FDA data

VioOne™ HIV Profile™ Supplemental Assay

Primary DI
00853214004001
Brand
VioOne™ HIV Profile™ Supplemental Assay
Company
AVIOQ, Inc.
Model
400024
Catalog number
400024
Device description
The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma.
Published
2022-10-18
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
00853214004001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853214004001008532140040018532140040010853214004001

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antigen/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 antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) 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
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
00853214004148Avioq HIV-I Microelisa System1009601009602014-09-24
00853214004155Avioq HIV-I Microelisa System1096001096002014-09-24