FDA.reportPublic FDA data

Avioq HTLV-I/II Microelisa System

Primary DI
00853214004032
Brand
Avioq HTLV-I/II Microelisa System
Company
AVIOQ, Inc.
Model
209600
Catalog number
209600
Device description
Avioq HTLV-I/II Microelisa System is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and/or Human T-Lymphotropic Virus Type II (HTLV-II) in human serum, plasma, and cadaveric specimens.
Published
2023-05-12
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
00853214004032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853214004032008532140040328532140040320853214004032

GMDN Terms#

Term, Definition table
TermDefinition
Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) 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 human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2) 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
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
00853214004148Avioq HIV-I Microelisa System1009601009602014-09-24
00853214004155Avioq HIV-I Microelisa System1096001096002014-09-24