AccessGUDID - DEVICE: InstaTest™ (00894175000619)

GUDID

Device Identifier (DI) Information

Brand Name: InstaTest™
Version or Model: DACD330-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 330-50
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00894175000619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.

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:	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?
51708	Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 50 Tests/Kit

Device Record Status

Public Device Record Key: 820b20fd-1cec-461b-8179-63938dc4fd81
Public Version Date: December 22, 2021
Public Version Number: 1
DI Record Publish Date: December 13, 2021