RaPET® ASO 1125-100

GUDID 00657498001233

Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antistreptolysin-O in non-diluted serum.

STANBIO LABORATORY, L.P.

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

• Primary Device ID: 00657498001233
• NIH Device Record Key: f6b76aaa-408d-44fd-ba95-ab6a4066773e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RaPET® ASO
• Version Model Number: 1125-100
• Catalog Number: 1125-100
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498001233 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [RaPET® ASO]

• 00657498001233: Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antist
• 00657498001226: Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Antist