The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set.
| Device ID | K221658 |
| 510k Number | K221658 |
| Device Name: | Non-variola Orthopoxvirus Real-time PCR Primer And Probe Set |
| Classification | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| Applicant | Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta, GA 30329 |
| Contact | Julie Villanueva, PhD |
| Correspondent | Julie Villanueva, PhD Centers For Disease Control And Prevention 1600 Clifton Road NE, MS: H24-11 Atlanta, GA 30329 |
| Product Code | NHT |
| CFR Regulation Number | 866.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-08 |
| Decision Date | 2022-06-10 |