The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Hsv 1&2 Dna Amplification Assay, Illumigene Hsv 1&2 External Control Kit, Illumipro-10.
| Device ID | K151046 |
| 510k Number | K151046 |
| Device Name: | Illumigene HSV 1&2 DNA Amplification Assay, Illumigene HSV 1&2 External Control Kit, Illumipro-10 |
| Classification | Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr Cincinnati, OH 45244 |
| Contact | Stefanie Johns |
| Correspondent | Stefanie Johns MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr Cincinnati, OH 45244 |
| Product Code | PGI |
| CFR Regulation Number | 866.3309 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733102219 | K151046 | 000 |
| 00840733102158 | K151046 | 000 |
| 00840733101182 | K151046 | 000 |
| 00840733101151 | K151046 | 000 |