STREPAIM

GUDID 00695684730406

A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs.

GERMAINE LABORATORIES, INC

Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00695684730406
• NIH Device Record Key: 8152afa4-9ebd-43ff-9afb-718835fa89a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STREPAIM
• Version Model Number: 73040
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684730401 [Unit of Use]
GS1	00695684730406 [Primary]

FDA Product Code

• GTY: Antigens, All Groups, Streptococcus Spp.

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: 2016-04-27

On-Brand Devices [STREPAIM]

• 00695684730406: A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat
• 00695684730253: A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat