Chrysalis Intelligence · Product Codes · PMN

PMN · Unclassified

18 clearances · 4 unique sponsors

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Device class

—

Regulation —

Total clearances

18

2020-04-02 → 2026-07-17

Last 12 months

5

Unique sponsors

4

Classification details

Medical specialty

—

Review panel

—

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
Maine Molecular Quality Controls, Inc.	9	1	2026-05-19
Streck, LLC	6	3	2026-03-27
Biofire Defense, LLC	2	1	2026-07-17
Zeptometrix	1	0	2022-02-02

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
87910	CPT	—	High	Nucleic acid amplification with internal positive control; external quality control material standard
88199	CPT	—	Medium	Laboratory quality control material; assayed external control for NAT assays

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-17	K261475	Biofire Defense, LLC	BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
2026-05-19	K260577	Maine Molecular Quality Controls, Inc.	FilmArray TF Control Panel M527
2026-03-27	K260041	Streck, LLC	MDx-Chex for BCP
2026-03-23	K254166	Streck	MDx-Chex for BCN
2026-03-17	K254167	Streck, LLC	MDx-Chex for BCY
2025-08-14	K251526	Maine Molecular Quality Controls, Inc.	FilmArray GI Control Panel M238
2024-05-30	K241289	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
2024-03-26	K233611	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
2023-07-27	K231223	Streck	MDx-Chex for BC-GN
2023-07-27	K231221	Streck	MDx-Chex for BC-GP
2023-04-13	K230868	Maine Molecular Quality Controls, Inc.	SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
2023-02-03	K221253	Maine Molecular Quality Controls, Inc.	SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
2022-07-22	K203680	Maine Molecular Quality Controls, Inc.	BioFire JI Control Panel M420
2022-02-02	K201403	Zeptometrix	NATtrol BD MAX Vaginal Panel External Controls
2022-01-19	K212576	Streck, Inc.	MDx-Chex for BCID2
2021-06-24	K202196	Maine Molecular Quality Controls, Inc.	BioFire RP2.1/RP2.1plus Control Panel M441
2020-11-20	K202382	Biofire Defense, LLC	FilmArray Global Fever Panel External Control Kit
2020-04-02	K200010	Maine Molecular Quality Controls, Inc.	FilmArray BCID2 Control Panel M416