gudid
Primary ID: 97736
ONE-STEP PLUS PREGNANCY (UDI 97736)
Manufactured by GERMAINE LABORATORIES, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONE-STEP PLUS PREGNANCY - Primary ID 97736
Device Regulatory Overview
The ONE-STEP PLUS PREGNANCY (Model/Catalog Number: 97736) is a medical device manufactured by GERMAINE LABORATORIES, INC. This product is indexed under FDA Product Code / Category Classification JHI within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 97736
- Product Code / EMDN
- JHI
- Device Name
- For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine.
- 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 ONE-STEP PLUS PREGNANCY?
The registered manufacturer of record for ONE-STEP PLUS PREGNANCY is GERMAINE LABORATORIES, INC.
What is the Primary UDI-DI identifier for ONE-STEP PLUS PREGNANCY?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 97736.
What classification code is assigned to this device?
This device is registered under product classification code JHI.
Similar Classification Devices (JHI)
Other Devices by GERMAINE LABORATORIES, INC
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