Who else makes this device?

Name: AmnioTest Colour Cards
Brand: AmnioTest Colour Cards

Obstetrics & Gynecology › DiagnosticSampler, Amniotic Fluid (Amniocentesis Tray)

AmnioTest Colour Cards

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…

Registry build 21.09.26

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

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code HIO
Manufacturer	City	Province	Registered as	Device types
Changzhou Meiguan Care Products Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	32

Record

Regulatory record for AmnioTest Colour Cards
Listed by	pro-lab incorporated, Canada
FDA product code	HIO
Device type	Sampler, Amniotic Fluid (Amniocentesis Tray)
Device class	Class 1
Regulation	21 CFR 884.1550
Establishment	Contract manufacturer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-12-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for AmnioTest Colour Cards
Catalogue number	Size	Status
PL.902		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	82
Echotip	Cook Incorporated	23
Aligned Medical Solutions	Aligned Medical Solutions	9
Amniocentesis Tray	Argon Medical Devices, Inc.	3
Stradis Healthcare	Stradis Healthcare	2
Amniocentesis Needle	Vitrolife Sweden AB	2
Amnicators	Medical Wire & Equipment Company (Bath), Ltd.	2
Busse Hospital Disposables	Robert Busse & Co., Inc.	2
AmnioTest (Nitrazine yellow swab)	pro-lab incorporated	1
Sampler, Amniotic Fluid (Amniocentesis Tray)	Carefusion 2200, Inc.	1
Stradis	Stradis Healthcare	1
AmnioTest (Nitrazine yellow swab 100 box)	pro-lab incorporated	1

Showing 12 of 17. All products under Sampler, Amniotic Fluid (Amniocentesis Tray)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K914419	1993-09-01

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.