CultureSwab™ MaxV
CultureSwab™ MaxV CultureSwab Max V LQ Stuart Double Plastic Applicators
11manufacturers in China registered for this device type
4catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Huachenyang(Shenzhen)Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Copan Italia, Italy |
|---|---|
| FDA product code | JSM |
| Device type | Culture Media, Non-Propagating Transport |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2390 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K946288 |
| Record published | 2023-03-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 220231 | 50 | In distribution | |
| 220234 | 50 | In distribution | |
| 220232 | 50 | In distribution | |
| 220233 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BioSci | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 27 |
| UTM® | Copan Italia | 18 |
| Bioer Viral Transport Medium | Hangzhou Bioer Technology Co., Ltd. | 15 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 13 |
| TransPorter® | Copan Italia | 13 |
| UTM-RT | Copan Italia | 12 |
| MicroTest M4RT | Remel, Inc. | 12 |
| BBL™ CultureSwab™ | Copan Italia | 11 |
| iClean | Huachenyang(Shenzhen)Technology Co., Ltd. | 11 |
| Gongdong | Zhejiang Gongdong Medical Technology Co., Ltd. | 11 |
| Transystem™ | Copan Italia | 10 |
| MicroTest M6 | Remel, Inc. | 9 |
Showing 12 of 98. All products under Culture Media, Non-Propagating Transport
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232565 | 2024-10-11 |
| K232357 | 2024-04-25 |
| K220052 | 2022-12-16 |
| K180052 | 2018-03-23 |
| K142094 | 2015-04-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cepheid | 510(k) number | 2024-06-20 | Class II | Under Investigation by firm | Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to tes | 651,150 |
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.