PrimeStore MTM
PrimeStore MTM is a molecular transport medium used to stabilize and transport nucleic acids from clinical specimens. The filed package contains 5 ml tubes filled with 1.5 ml of medium,…
PrimeStore MTM is a molecular transport medium used to stabilize and transport nucleic acids from clinical specimens. The filed package contains 5 ml tubes filled with 1.5 ml of medium, supplied in a 50-tube bag.
The medium accompanies an unprocessed human sample through collection and transport for molecular testing. It is the liquid transport medium used before downstream molecular analysis.
Listed Item
PrimeStore MTM 5 ml tubes with 1.5 ml fill in 50 tube bag
Tube and Medium
The tube holds the transport medium with space for a human specimen to be added. The medium stabilizes nucleic acids as the sample moves through collection and transport toward molecular testing.
PrimeStore MTM is a transport medium used before downstream molecular analysis. The filed tube size, fill and bag quantity identify this packaged configuration.
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 | Longhorn Vaccines and Diagnostics LLC, United States |
|---|---|
| FDA product code | QBD |
| Device type | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class 2 |
| Regulation | 21 CFR 866.2950 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | DEN170029 |
| Record published | 2025-11-03 |
| Record revised | 2026-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2028-05-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PSMTM-0201-50 | 50 | In distribution | |
| PSMTM-1203-100 | 100 | In distribution | |
| PSMTM-1202-1000 | 1,000 | In distribution | |
| PSMTM-0515-100 | 100 | In distribution | |
| PSMTM-1202-100 | 100 | In distribution | |
| PSMTM-1203-1000 | 1,000 | In distribution | |
| PSMTM-0515-1000 | 1,000 | In distribution | |
| PSMTM-0315 | 50 | In distribution | |
| PSMTM-0515-50 | 50 | In distribution | |
| PSMTM-0515-500 | 500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dakewe | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 12 |
| 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 |
|---|---|
| DEN170029 | 2018-03-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2020-06-03 | Class II | Error in labeling | The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they | 1,936,050 |
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.