eNAT®
The filing names Copan eNAT as a molecular collection and preservation medium and lists the 6U072S collection format. The stated use is to stabilize, transport and inactivate an unprocessed…
The filing names Copan eNAT as a molecular collection and preservation medium and lists the 6U072S collection format.
The stated use is to stabilize, transport and inactivate an unprocessed upper-respiratory specimen suspected of containing influenza A virus RNA.
Collection Format
The filing describes 6U072S as a plastic screw-cap tube containing two milliliters of medium. It distinguishes this format from a second listed variant supplied with a regular nylon flocked swab.
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 | Copan Italia, Italy |
|---|---|
| FDA product code | QBD |
| Device type | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class 2 |
| Regulation | 21 CFR 866.2950 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K201849 |
| Record published | 2021-02-16 |
| Record revised | 2022-11-14 (version 4) |
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, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6U073S01 | 50 | In distribution | |
| 6U072S | 50 | In distribution | |
| 6U074S01 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakewe | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 12 |
| PrimeStore MTM | Longhorn Vaccines and Diagnostics LLC | 10 |
| PurSafe+ | Puritan Medical Products Company LLC | 4 |
| Magbio Genomics, Inc. | Magbio Genomics Inc. | 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 |
|---|---|
| K201849 | 2020-09-17 |
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.