Identity
- Trade Name
- MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
- Device Name
- MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV FDA UDI
- Model / Reference
- 800348 FDA UDI
- Description
- MGB Alert® HSV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV (Herpes Simplex Virus). The mix consists of a total of 24.8 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 141 nucleic acid sequence from the glycoprotein D region of HSV FDA UDI
Identifiers
- Catalog Number
- 800348 FDA UDI
- Primary DI / UDI-DI
- 03661540951350 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn by ELITechGroup MDX LLC. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI 85c7a041-08c4-47af-8fb9-dc444c27ba6d 36 fields · synced May 30, 2026