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PRE · Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Microbiology · 3 clearances · 2 unique sponsors

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Device class

Class II

Regulation 866.3215

Total clearances

2021-11-29 → 2025-01-10

Last 12 months

Unique sponsors

Definition

What is Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.3215

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Immunexpress, Inc.	2	0	2023-12-15
Inflammatix, Inc.	1	0	2025-01-10

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
81519	CPT	—	High	Quantitative reverse transcription PCR (RT-qPCR) assay for gene expression measurement
81479	CPT	—	Medium	Unlisted molecular pathology procedure if specific immune biomarker codes unavailable

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-01-10	K241676	Inflammatix, Inc.	TriVerity
2023-12-15	K232095	Immunexpress, Inc.	SeptiCyte RAPID
2021-11-29	K203748	Immunexpress, Inc.	SeptiCyte RAPID