PrimeStore MTM
- Primary DI
- B903051550
- Brand
- PrimeStore MTM
- Company
- Longhorn Vaccines And Diagnostics, LLC
- Model
- PSMTM-0515-50
- Device description
- PrimeStore MTM 5 ml tubes with 1.5 ml fill in 50 tube bag
- Published
- 2024-02-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| QBD | Microbial Nucleic Acid Storage And Stabilization Device |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | Microbiology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| DEN170029 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B90305151 | Primary | HIBCC | 0 | |
| B903051550 | Unit of Use | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Oral/upper respiratory tract specimen collection kit | A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 019654346
- Device count
- 50
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B9030515500 | PrimeStore MTM | PSMTM-0515-500 | 2024-03-20 | |
| B90305151000 | PrimeStore MTM | PSMTM-0515-1000 | 2024-02-27 | |
| B90312002100 | PrimeStore MTM | PSMTM-1202-100 | 2024-02-07 | |
| B9031203100 | PrimeStore MTM | PSMTM-1203-100 | 2024-02-07 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07898996204648 | Molecular Transport Media (MTM) 2ml | A. L. B. LUZ | QBD | 2024-08-29 |
| 07898996204655 | Molecular Transport Media (MTM) 3ml | A. L. B. LUZ | QBD | 2024-08-29 |
| 05411967003471 | InActiv Blue | Fertipro NV | QBD | 2024-08-14 |
| 06973843228914 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | QBD | 2024-07-15 |
| 26973471968781 | DTPM | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2024-06-07 |
| 06973471968763 | DTPM | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2024-05-20 |
| B9030515500 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | QBD | 2024-03-20 |
| B90305151000 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | QBD | 2024-02-27 |
| B90312002100 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | QBD | 2024-02-07 |
| B9031203100 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | QBD | 2024-02-07 |
| 06973471968503 | BioSci™ | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2024-02-01 |
| 06973471968510 | BioSci™ | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2024-02-01 |
| 06973471968527 | BioSci™ | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2024-02-01 |
| 00860011194507 | DNA/RNA Shield™ SafeCollect Saliva Collection Kit | Blue Life Solutions, LLC | QBD | 2024-01-01 |
| 00850015033001 | BioMAX | Spectrum Solutions L.L.C. | QBD | 2023-06-21 |
| 06973471960507 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960514 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960521 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960538 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960545 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960552 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960569 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960576 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960583 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960590 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960606 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973471960613 | Dakewe | Shenzhen Dakewe Bio-engineering Co., Ltd | QBD | 2023-02-21 |
| 06973843228143 | BIOER Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | QBD | 2023-01-11 |
| 00850027600024 | DNA/RNA Shield Collection Tube with Swab (1mL) | Zymo Research Corp. | QBD | 2022-03-01 |
| 00850027600031 | DNA/RNA Shield Collection Tube with Swab (2mL) | Zymo Research Corp. | QBD | 2022-03-01 |