The following data is part of a premarket notification filed by Viro Research, Inc. with the FDA for Viro Varicella-zoster Virus Identification Reagent.
| Device ID | K942743 |
| 510k Number | K942743 |
| Device Name: | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT |
| Classification | Antigen, Cf, (including Cf Control), Varicella-zoster |
| Applicant | VIRO RESEARCH, INC. 5301 EAST STATE ST., #307A Rockford, IL 61108 |
| Contact | Abbas Vafai |
| Correspondent | Abbas Vafai VIRO RESEARCH, INC. 5301 EAST STATE ST., #307A Rockford, IL 61108 |
| Product Code | GQW |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002913506 | K942743 | 000 |
| 00860002913513 | K942743 | 000 |