Identity
- Trade Name
- HSV 1&2 ELITe MGB Assay for CE-IVD FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
- Device Name
- The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. FDA UDI
- Model / Reference
- RTK403ING FDA UDI
- Description
- The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. FDA UDI
Identifiers
- Catalog Number
- RTK403ING FDA UDI
- Primary DI / UDI-DI
- 03661540951947 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV 1&2 ELITe MGB Assay for CE-IVD by ELITechGroup MDX LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 05c91df0-f11e-4dd6-bae7-d58f3f885b38 35 fields · synced Jun 8, 2026