Identity
- Trade Name
- Alethia™ HSV 1&2 External Control Kit FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
- Device Name
- The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program. FDA UDI
- Model / Reference
- 479960 FDA UDI
- Description
- The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program. FDA UDI
Identifiers
- Catalog Number
- 479960 FDA UDI
- Primary DI / UDI-DI
- 00840733102158 FDA UDI
- 510(k) Number
- K151046 FDA UDI
- FDA Product Code
- PGI 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
- 866.3309 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Alethia™ HSV 1&2 External Control Kit by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control.
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- MGB Alert HSV 1&2 Typer Primer Mix ASR - 480 rxn — ELITechGroup MDX LLC. · Class I
- MGB Alert HSV-2 Primer Mix ASR 09N45-003 — ELITechGroup MDX LLC. · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
- MGB Alert HSV-1 Probe Mix ASR, 09N44-002 — ELITechGroup MDX LLC. · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
- Exact Diagnostics — Exact Diagnostics · Class I
Cleared under the same submission
K151046 also covers:
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
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI 8ea1134d-a143-4540-8793-8e752ddf7649 36 fields · synced May 30, 2026