gudid
Primary ID: 97036
ONESTEP PREGNANCY (UDI 97036)
Manufactured by GERMAINE LABORATORIES, INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ONESTEP PREGNANCY - Primary ID 97036
Device Regulatory Overview
The ONESTEP PREGNANCY (Model/Catalog Number: 97036) 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
- 97036
- Product Code / EMDN
- JHI
- Device Name
- Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in 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 ONESTEP PREGNANCY?
The registered manufacturer of record for ONESTEP PREGNANCY is GERMAINE LABORATORIES, INC.
What is the Primary UDI-DI identifier for ONESTEP PREGNANCY?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 97036.
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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