FDA.reportPublic FDA data

Avioq HTLV-I/II Microelisa System

Primary DI
00853214004094
Brand
Avioq HTLV-I/II Microelisa System
Company
Avioq, Inc.
Model
509600
Catalog number
509600
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
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853214004094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853214004094008532140040948532140040940853214004094

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
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 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
00853214004131Avioq HIV-I Microelisa System1003841003842014-09-24
00853214004148Avioq HIV-I Microelisa System1009601009602014-09-24
00853214004155Avioq HIV-I Microelisa System1096001096002014-09-24