Device class
Class II
Regulation 862.1155
Total clearances
3
2022-01-31 → 2026-09-22
Classification details
Medical specialty
Clinical Chemistry
Regulation number
862.1155
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Alfa Scientific Designs, Inc. |
1 |
1 |
2026-09-22 |
|
Hangzhou AllTest Biotech Co., Ltd.
|
1 |
0 |
2022-01-31 |
|
Innovita (Tangshan) Biological Technology Co., Ltd. |
1 |
0 |
2024-08-02 |
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 |
| 84703 |
CPT
|
— |
High
|
Standard CPT for human chorionic gonadotropin (hCG) quantitation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-22 |
K262299 |
Alfa Scientific Designs, Inc.
|
Instant-View® hCG Combo II Cassette Test |
| 2024-08-02 |
K241919 |
Innovita (Tangshan) Biological Technology Co., Ltd.
|
Innovita HCG Pregnancy Rapid Combo Test |
| 2022-01-31 |
K203272 |
Hangzhou AllTest Biotech Co., Ltd.
|
Alltest Pregnancy Rapid Combo Test Cassette |