AccessGUDID - DEVICE: Avioq HTLV-I/II Microelisa System (00853214004025)

GUDID

Device Identifier (DI) Information

Brand Name: Avioq HTLV-I/II Microelisa System
Version or Model: 200576
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200576
Company Name: AVIOQ, Inc.

Primary DI Number: 00853214004025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 195645259 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48523	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d39fe1b5-2eba-4e2e-9a96-222eb3d56063
Public Version Date: September 30, 2024
Public Version Number: 2
DI Record Publish Date: May 12, 2023