← Back to catalogue
R12576 M4RTUniversal Plus Swab Kit PK/100
FDA UDIClass I (US FDA UDI)
by Remel, Inc.
Identity
- Trade Name
- R12576 M4RTUniversal Plus Swab Kit PK/100 FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
- Model / Reference
- R12576 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838018510 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 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
No
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/respiratory tract specimen container IVD, additive/medium
R12576 M4RTUniversal Plus Swab Kit PK/100 by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/respiratory tract specimen container IVD, additive/medium.
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- SalivaGene Collector — Invitek Molecular GmbH · Class I
- SalivaGene Swab Comfort — Invitek Molecular GmbH · Class I
- SpeciMAX Dx Stabilized Saliva Collection Kit — LIFE TECHNOLOGIES LIMITED · Class I
- BioMAX — Spectrum Solutions L.L.C. · Class II
- BioSci™ — Shenzhen Dakewe Bio-engineering Co., Ltd · Class II
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- Dakewe — SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 88077269-75ef-4401-9725-53cdc60acc4f 32 fields · synced May 30, 2026