Identity
- Trade Name
- LightCycler® MRSA Advanced Test FDA UDI
- Generic Name
- MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Catalog Number
- 05205727190 FDA UDI
- Primary DI / UDI-DI
- 00875197002973 FDA UDI
- FDA Product Code
- NQX FDA UDIOOI FDA UDI
- GMDN Term
- MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 FDA UDI862.2570 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
No
FDA UDI
Prescription Use
No
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: MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)
LightCycler® MRSA Advanced Test by Roche Molecular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRSA nucleic acid IVD, kit, nucleic acid technique (NAT).
- Xpert MRSA NxG — CEPHEID · Class II
- Xpert MRSA — CEPHEID · Class II
- Xpert MRSA — CEPHEID · Class II
- Staph ID/R Blood Culture Panel — Great Basin Scientific, Inc. · Class II
- BD MAX™ MRSA XT — BECTON DICKINSON AND COMPANY · Class II
- Xpert MRSA NxG — CEPHEID · 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI d0cf4d76-f4f1-4aae-ab8c-72697948cf8a 33 fields · synced Jun 9, 2026