AmnioTest (Nitrazine Yellow Swab 20 Box)
Catalogue number PL.901-20, listed by pro-lab incorporated, Canada, under Sampler, Amniotic Fluid (Amniocentesis Tray). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| 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 |
| 510(k) | K914419 |
| Record published | 2022-12-26 |
| Record revised | 2026-04-27 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Microwave Radiation |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PL.901-20 | In distribution |
Same 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
| 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.