Chrysalis Intelligence · Product Codes · LSR

LSR · Unclassified

15 clearances · 7 unique sponsors

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Device class

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Regulation —

Total clearances

15

2020-01-29 → 2026-07-10

Last 12 months

2

Unique sponsors

7

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
Gold Standard Diagnostics	6	0	2021-03-22
DiaSorin, Inc.	3	0	2021-02-18
Id-Fish Technology, Inc.	2	0	2025-06-12
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	1	1	2026-07-10
Zeus Scientific	1	0	2023-07-13
Viramed Biotech AG	1	0	2022-08-19
Inanovate, Inc.	1	1	2025-11-14

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
86617	CPT	—	Medium	Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (e.g., Western blot or immunoblot)
86618	CPT	—	Medium	Antibody; Borrelia burgdorferi (Lyme disease)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-10	K254295	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	Sofia Lyme FIA; Sofia 2 Campylobacter FIA
2025-11-14	K252627	Inanovate, Inc.	Lyme-ID IgG Test; Bio-ID800
2025-06-12	K242872	Id-Fish Technology, Inc.	iDart Lyme IgM ImmunoBlot Kit
2024-08-12	K233367	Id-Fish Technology, Inc.	iDart Lyme IgG ImmunoBlot Kit
2023-07-13	K230863	Zeus Scientific	ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
2022-08-19	K220016	Viramed Biotech AG	Viramed Borrela All-In-One ViraChip Test Kit
2021-03-22	K203296	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
2021-03-22	K203295	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
2021-03-22	K203292	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
2021-03-22	K203289	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
2021-02-18	K202574	DiaSorin, Inc.	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
2021-02-18	K202573	DiaSorin, Inc.	LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
2020-04-06	K200025	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
2020-04-06	K200023	Gold Standard Diagnostics	Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
2020-01-29	K193051	DiaSorin, Inc.	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set