AccessGUDID - DEVICE: INSTI HIV-1/HIV-2 Test Controls (06865978010376)

GUDID

Device Identifier (DI) Information

Brand Name: INSTI HIV-1/HIV-2 Test Controls
Version or Model: 80-1037
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80-1037
Company Name: Biolytical Laboratories Inc

Primary DI Number: 06865978010376
Issuing Agency: GS1
Commercial Distribution End Date: June 24, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 201060071 *Terms of Use

Device Description: INSTI HIV-1/HIV-2 Test Controls

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
48432	HIV1/HIV2 antigen IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZF	Test, Hiv Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP090032	7

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 2 and 8 Degrees Celsius
Storage Environment Temperature: between -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35c30569-e539-43db-977f-d330686556a7
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: August 21, 2015