The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Amiplivue Hsv 1&2 Assay.
| Device ID | K140029 |
| 510k Number | K140029 |
| Device Name: | AMIPLIVUE HSV 1&2 ASSAY |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar QUIDEL CORPORATION 10165 MCKELLAR COURT San Diego, CA 92121 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-06 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613312109 | K140029 | 000 |