Identity
- Trade Name
- MASTALEX-MRSA FDA UDI
- Generic Name
- Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit FDA UDI
- Device Name
- MASTALEX-MRSA Rapid latex test for the detection of M.R.S.A. FDA UDI
- Model / Reference
- RST501 FDA UDI
- Description
- MASTALEX-MRSA Rapid latex test for the detection of M.R.S.A. FDA UDI
Identifiers
- Catalog Number
- RST501 FDA UDI
- Primary DI / UDI-DI
- 15060392372705 FDA UDI
- 510(k) Number
- K062864 FDA UDI
- FDA Product Code
- MYI FDA UDI
- GMDN Term
- Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Staphylococcus aureus culture isolate identification/methicillin susceptibility testing IVD, kit
Mastalex-Mrsa by Mast Group , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Mast Group , Ltd.
Sources (1)
- FDA UDI 70e5c216-897a-4e1d-9679-2bc5cd7e5bc6 36 fields · synced May 30, 2026