Chrysalis Intelligence · Product Codes · OZE

OZE · Unclassified

6 clearances · 3 unique sponsors

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Device class

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Regulation —

Total clearances

6

2020-03-10 → 2025-07-11

Last 12 months

0

Unique sponsors

3

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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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	4	0	2025-07-11
Abbott Diagnostics Scarborough, Inc.	1	0	2022-06-24
Quidel Corporation	1	0	2023-03-03

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.

Code	Type	Description	Confidence	Rationale
87502	CPT	—	High	Influenza A and B nucleic acid assay with multiple primers/probes; standard multiplex influenza testing code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-07-11	K243274	Centers for Disease Control and Prevention	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
2025-03-14	K243931	Centers for Disease Control and Prevention	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
2024-05-21	K241110	Centers for Disease Control and Prevention	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
2023-03-03	K230236	Quidel Corporation	Lyra Influenza A+B Assay
2022-06-24	K220801	Abbott Diagnostics Scarborough, Inc.	ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
2020-03-10	K200370	Centers for Disease Control and Prevention	CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit