GUDIDData
gudid Primary ID: 97733

AIMSTEP COMBO PREGNANCY (UDI 97733)

Manufactured by GERMAINE LABORATORIES, INC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AIMSTEP COMBO PREGNANCY - Primary ID 97733

Device Regulatory Overview

The AIMSTEP COMBO PREGNANCY (Model/Catalog Number: 97733) 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
97733
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

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of AIMSTEP COMBO PREGNANCY?

The registered manufacturer of record for AIMSTEP COMBO PREGNANCY is GERMAINE LABORATORIES, INC.

What is the Primary UDI-DI identifier for AIMSTEP COMBO PREGNANCY?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 97733.

What classification code is assigned to this device?

This device is registered under product classification code JHI.

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