Chrysalis Intelligence · Product Codes · LYR

LYR · Helicobacter Pylori

Microbiology · 3 clearances · 2 unique sponsors

Device class
Class I
Regulation 866.3110
Total clearances
3
2020-03-13 → 2023-12-15
Last 12 months
0
Unique sponsors
2
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.3110
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Meridian Bioscience, Inc. 2 0 2023-07-03
Biomerica, Inc. 1 0 2023-12-15
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
87906 CPT High CPT code for Helicobacter pylori, non-amplified probe technique
87907 CPT High CPT code for Helicobacter pylori, amplified probe technique
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-12-15 K232892 Biomerica, Inc. Hp Detect™ Stool Antigen ELISA
2023-07-03 K230901 Meridian Bioscience, Inc. Premier HpSA Flex (619096)
2020-03-13 K192817 Meridian Bioscience, Inc. Curian HpSA, Curian Analyzer