QuickVue
QkVue Strep A Dpstk, 4T Samp
6manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this 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 | Quidel Corp., United States |
|---|---|
| FDA product code | GTY |
| Device type | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K011097 |
| Record published | 2019-03-07 |
| Record revised | 2025-11-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | expiry date |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20163 | In distribution | |
| 20125 | In distribution | |
| 20152 | In distribution | |
| 20108 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Sofia | 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.
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171976 | 2017-12-21 |
| K141775 | 2014-12-16 |
| K123793 | 2013-06-17 |
| K011097 | 2001-05-08 |
| K945080 | 1995-02-10 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Quidel Corp. | 510(k) number | 2026-04-06 | Class II | Under Investigation by firm | Product has the potential for false positive results | 12279 units |
| Quidel Corp. | 510(k) number | 2025-06-17 | Class II | Under Investigation by firm | Dipstick strep A test has potential for false positive results. | 22470 |
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.