InstaTest™ 330-50

GUDID 00894175000619

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.

Diagnostic Automation, Inc.

Beta-haemolytic Group A Streptococcus antigen IVD, kit, agglutination

• Primary Device ID: 00894175000619
• NIH Device Record Key: 820b20fd-1cec-461b-8179-63938dc4fd81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaTest™
• Version Model Number: DACD330-50
• Catalog Number: 330-50
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894175000619 [Primary]

FDA Product Code

• GTQ: Antistreptolysin - Titer/Streptolysin O Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [InstaTest™]

• 00894175000619: ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitativ
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