gudid
Primary ID: 75525
StrepAim (UDI 75525)
Manufactured by GERMAINE LABORATORIES, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for StrepAim - Primary ID 75525
Device Regulatory Overview
The StrepAim (Model/Catalog Number: 75525) is a medical device manufactured by GERMAINE LABORATORIES, INC. This product is indexed under FDA Product Code / Category Classification GTY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 75525
- Product Code / EMDN
- GTY
- Device Name
- A rapid dipstick test for the qualitative detection of group A streptococcal antigen from throat swabs
- Database Sync Date
- 2026-08-09 09:04:20
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of StrepAim?
The registered manufacturer of record for StrepAim is GERMAINE LABORATORIES, INC.
What is the Primary UDI-DI identifier for StrepAim?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 75525.
What classification code is assigned to this device?
This device is registered under product classification code GTY.
Similar Classification Devices (GTY)
Other Devices by GERMAINE LABORATORIES, INC
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