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Molecular Transport Media (MTM) 2ml
FDA UDIClass II (US FDA UDI)
by A. L. B. Luz
Identity
- Trade Name
- Molecular Transport Media (MTM) 2ml FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit FDA UDI
- Device Name
- The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices. FDA UDI
- Model / Reference
- MEI00218 FDA UDI
- Description
- The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices. FDA UDI
Identifiers
- Catalog Number
- MEI00218 FDA UDI
- Primary DI / UDI-DI
- 07898996204648 FDA UDI
- 510(k) Number
- K233324 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral/upper respiratory tract specimen collection kit
Molecular Transport Media (MTM) 2ml by A. L. B. Luz — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233324 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A. L. B. Luz
Sources (1)
- FDA UDI 42f2173c-bc34-4005-a689-e2a7cf392645 35 fields · synced May 30, 2026