AmnioTest Colour Cards

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name: AmnioTest Colour Cards FDA UDI
Generic Name: Amniotic fluid leak detector FDA UDI
Device Name: AmnioTestTM is designed to assist in the detection of rupture of the fetal membrane. It offers the most efficient, cost effective, reliable, and simple to use point-of-care screen test to aid in the detection of amniotic fluid in near-term patients. Along with a simple quality control regimen, AmnioTestTM is an invaluable tool for OB-GYN and L+D clinics. 50 cards FDA UDI
Model / Reference: PL.902 FDA UDI
Description: AmnioTestTM is designed to assist in the detection of rupture of the fetal membrane. It offers the most efficient, cost effective, reliable, and simple to use point-of-care screen test to aid in the detection of amniotic fluid in near-term patients. Along with a simple quality control regimen, AmnioTestTM is an invaluable tool for OB-GYN and L+D clinics. 50 cards FDA UDI

Identifiers

Catalog Number: PL.902 FDA UDI
Primary DI / UDI-DI: 10628429001254 FDA UDI
FDA Product Code: HIO FDA UDI
GMDN Term: Amniotic fluid leak detector FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.1550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Amniotic fluid leak detector

AmnioTest Colour Cards by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Pro-Lab, Incorporated

Sources (1)

FDA UDI 61cf6649-a1fd-46f2-b3be-e4cfa8e7a6bd 34 fields · synced May 30, 2026