McKesson
Test, KIT Strep A Dipstick WAI
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 |
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | GTY |
| Device type | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Record published | 2020-03-13 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4999 | 50 | In distribution | |
| 181-34225 | 50 | In distribution | |
| 5003 | 25 | In distribution | |
| 181-34125 | 25 | In distribution | |
| 181-34225 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sofia | Quidel Corp. | 4 |
| QuickVue | Quidel Corp. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| Strepaim | Germaine Laboratories, Inc. | 3 |
| Rapid Response | Btnx Inc. | 3 |
| Status Strep A Flip | Princeton BioMeditech Corp. | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Icon | Beckman Coulter, Inc. | 2 |
| Poly stat | Polymedco, Inc. | 2 |
| Group B Streptococcus Detection Kit(Immunochromatography) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
| Status Strep A Plus | Princeton BioMeditech Corp. | 2 |
| BioStrep® A | Princeton BioMeditech Corp. | 2 |
Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2022-05-25 | Class II | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT |
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.