# Andon Medical co., LTD (contract manufacturer, Tianjin, CN): 2 new FDA device listings, incl. multi-analyte respiratory virus antigen detection test

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Andon Medical co., LTD |
| Owner / operator | Andon Medical Co.,Ltd |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Tianjin, CN |
| New listings | 2 |
| Devices | Multi-Analyte Respiratory Virus Antigen Detection Test; Clinical Electronic Thermometer |
| Product codes | SCA, SDV |
| Device classes | Class II |
| Medical specialties | Microbiology, General Hospital |
| Brand names | iHealth Flu A&B/COVID-19 Rapid Test Pro; iHealth Flu A&B/COVID-19 Rapid Test Pro Control Kit; iHealth Flu A&B/COVID-19 Rapid Test; iHealth (model: PT3); iHealth Infrared No-Touch Forehead Thermometer (model:PT9S); iHealth (model: PT1); iHealth (model: PT9L); Infrared Digital No-Touch Thermometer (model:PT2L) |
| First new listing | 2026-05-25 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3008573045 |
| Registration expires | 2027-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.