Microbiology · 14 clearances · 13 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| ACON Laboratories, Inc. | 2 | 0 | 2024-04-19 |
| Ihealth Labs, Inc. | 1 | 0 | 2024-05-31 |
| Healgen Scientific,, LLC | 1 | 1 | 2026-04-13 |
| Osang, LLC | 1 | 0 | 2025-05-30 |
| Access Bio, Inc. | 1 | 0 | 2025-01-29 |
| Assure Tech., LLC | 1 | 1 | 2026-06-05 |
| Genbody.Inc. | 1 | 1 | 2026-03-13 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 0 | 2025-02-11 |
| CorDx, Inc. | 1 | 0 | 2024-06-21 |
| Genabio Diagnostics, Inc. | 1 | 1 | 2025-09-05 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 0 | 2024-09-30 |
| Quidel Corporation | 1 | 0 | 2024-03-22 |
| InBios International, Inc. | 1 | 1 | 2025-10-12 |
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 |
|---|---|---|---|---|
| 86769 | CPT | — | High | SARS-CoV-2 antigen detection by immunoassay, rapid qualitative test |
| U0002 | HCPCS | 2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc ✓ CMS-verified description | High | SARS-CoV-2 antigen detection COVID-19 test, non-lab setting |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-06-05 | K260754 | Assure Tech., LLC | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test |
| 2026-04-13 | K260095 | Healgen Scientific,, LLC | Heal-Check Rapid COVID-19 Antigen Self-Test |
| 2026-03-13 | K251916 | Genbody.Inc. | GenBody COVID-19 Ag Home Test |
| 2025-10-12 | K251595 | InBios International, Inc. | COVID-19 Detect Rapid Self -Test |
| 2025-09-05 | K251753 | Genabio Diagnostics, Inc. | GenaCheck COVID-19 Rapid Self-Test |
| 2025-05-30 | K241313 | Osang, LLC | OHC COVID-19 Antigen Self Test |
| 2025-02-11 | K243518 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Antigen Self Test |
| 2025-01-29 | K241915 | Access Bio, Inc. | CareSuperb COVID-19 Antigen Home Test |
| 2024-09-30 | K241317 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) |
| 2024-06-21 | K240728 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test |
| 2024-05-31 | K233842 | Ihealth Labs, Inc. | iHealth COVID-19 Antigen Rapid Test |
| 2024-04-19 | K233373 | ACON Laboratories, Inc. | Flowflex® Plus COVID-19 Home Test |
| 2024-03-22 | K231795 | Quidel Corporation | QuickVue COVID-19 Test |
| 2023-11-09 | K230828 | ACON Laboratories, Inc. | Flowflex COVID-19 Antigen Home Test |