Dakewe
2 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs. 50 tests per package.
3manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Shenzhen Dakewe BIO-Engineering Co., Ltd., China |
|---|---|
| FDA product code | QBD |
| Device type | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class 2 |
| Regulation | 21 CFR 866.2950 |
| Establishment | Manufacturer |
| 510(k) | K220059 |
| Record published | 2023-02-21 |
| Record revised | 2023-10-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ITMM | In distribution | |
| ITMM | In distribution | |
| ITMT | In distribution | |
| ITMM | In distribution | |
| ITMO | In distribution | |
| ITMO | In distribution | |
| ITMO | In distribution | |
| ITMN | In distribution | |
| ITMT | In distribution | |
| ITMN | In distribution | |
| ITMN | In distribution | |
| ITMT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PrimeStore MTM | Longhorn Vaccines and Diagnostics LLC | 10 |
| PurSafe+ | Puritan Medical Products Company LLC | 4 |
| Magbio Genomics, Inc. | Magbio Genomics Inc. | 3 |
| eNAT® | Copan Italia | 3 |
| BioSci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 3 |
| Dtpm | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 2 |
| Zhejiang Gene Science | Zhejiang Gene Science Co., Ltd. | 2 |
| Xpert Swab Specimen Collection Kit | Cepheid | 1 |
| Bioer Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 1 |
| BioMAX | Spectrum Solutions L.L.C. | 1 |
| Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 1 |
| Molecular Transport Media (MTM) 2ml | A. L. B. LUZ | 1 |
Showing 12 of 14. All products under Microbial Nucleic Acid Storage And Stabilization Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220059 | 2023-01-19 |
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.