Identity
- Trade Name
- MRSA/SA ELITe MGB FDA UDI
- Generic Name
- MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. FDA UDI
- Model / Reference
- M800346 FDA UDI
- Description
- MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540950001 FDA UDI
- 510(k) Number
- K112937 FDA UDI
- FDA Product Code
- NQX FDA UDI
- GMDN Term
- MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT) 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
No
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
Yes
FDA UDI
Category: MRSA/MSSA nucleic acid IVD, kit, nucleic acid technique (NAT)
MRSA/SA ELITe MGB by ELITechGroup MDX LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Xpert MRSA/SA Blood Culture — CEPHEID · Class II
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- Xpert MRSA/SA SSTI — 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 |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI b3cdd036-7c3d-47b3-899f-c2adf32ff9d5 35 fields · synced Jun 7, 2026