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AmnioTest (Nitrazine yellow swab)

FDA UDI

Class I (US FDA UDI)

by Pro-Lab, Incorporated

Identity

Trade Name
AmnioTest (Nitrazine yellow swab) FDA UDI
Generic Name
Amniotic fluid leak detector FDA UDI
Device Name
The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM. FDA UDI
Model / Reference
PL.901 FDA UDI
Description
The AmnioTest™ is designed to assist in the detection of rupture of the fetal membranes, based on elevation of the pH in the upper vagina consistent with leakage of amniotic fluid. The sterile swab impregnated with nitrazine yellow dye, offers a rapid, reliable, cost effective and simple to use point-of-care test to aid in the detection of amniotic fluid in patients with suspected PROM. FDA UDI

Identifiers

Catalog Number
PL.901 FDA UDI
Primary DI / UDI-DI
10628429001223 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Microwave Radiation FDA UDI

Category: Amniotic fluid leak detector

AmnioTest (Nitrazine yellow swab) by Pro-Lab, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniotic fluid leak detector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pro-Lab, Incorporated

Sources (1)

  • FDA UDI 83190e6e-898c-4e92-aa00-3cbb2d1d4fa7 34 fields · synced May 30, 2026