Identity
- Trade Name
- PrimeStore MTM FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit FDA UDI
- Device Name
- PrimeStore MTM 5ml tube 1.5 ml fill Box of 1000 FDA UDI
- Model / Reference
- PSMTM-0515-1000 FDA UDI
- Description
- PrimeStore MTM 5ml tube 1.5 ml fill Box of 1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B90305153 FDA UDI
- 510(k) Number
- DEN170029 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General specimen container IVD, additive/mediumOral/upper respiratory tract specimen collection kitOral/upper respiratory tract specimen collection kit IVD, clinicalOral/respiratory tract specimen container IVD, additive/medium
PrimeStore MTM by Longhorn Vaccines and Diagnostics LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN170029 also covers:
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Longhorn Vaccines and Diagnostics LLC
Sources (1)
- FDA UDI 9ec7cba2-1932-424a-a570-0743bccfdb60 35 fields · synced May 30, 2026