Status Strep a Plus
Status Strep A Plus; 50 Test kit (2 x 25 Test Strip Canister)
6manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Princeton BioMeditech Corp., United States |
|---|---|
| FDA product code | GTY |
| Device type | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Manufacturer, Exporter |
| Record published | 2016-09-23 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSP-185-50-01 | In distribution | |
| BSP-185-05-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| 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 |
| BioStrep® A | Princeton BioMeditech Corp. | 2 |
Showing 12 of 148. All products under Antigens, All Groups, Streptococcus Spp.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082661 | 2008-10-06 |
| K040708 | 2004-11-22 |
| K983386 | 1998-11-25 |
| K971349 | 1997-07-07 |
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.