Chrysalis Intelligence · Product Codes · PBK

PBK · Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Microbiology · 3 clearances · 1 unique sponsors

Device class
Class II
Regulation 866.3315
Total clearances
3
2022-06-10 → 2022-08-30
Last 12 months
0
Unique sponsors
1
Definition

What is Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.3315
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Centers for Disease Control and Prevention 3 0 2022-08-30
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87701 CPT Medium PCR assay for viral detection; orthopoxvirus real-time PCR nucleic acid detection
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2022-08-30 K222558 Centers for Disease Control and Prevention Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
2022-06-24 K221834 Centers for Disease Control and Prevention Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
2022-06-10 K221658 Centers for Disease Control and Prevention Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set