# Abbott Molecular, Inc. (manufacturer, Des Plaines, IL): 2 new FDA device listings, incl. multi-target respiratory specimen nucleic acid test including sars-cov

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Abbott Molecular, Inc. |
| Owner / operator | Abbott Laboratories |
| Role | Manufacturer |
| Establishment types | Manufacture Device in the United States for Export Only; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Des Plaines, IL, US |
| New listings | 2 |
| Devices | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents; Applicator, Absorbent Tipped, Sterile |
| Product codes | QOF, KXG |
| Device classes | Class I, Class II |
| Medical specialties | Microbiology, General Hospital |
| Brand names | Alinity m Resp-4-Plex CTRL Kit; Alinity m Resp-4-Plex AMP Kit; Alinity m Resp-4-Plex Application Specification File; Specimen Collection Swab (09R20-002); Specimen Collection Swab (09R20-001) |
| First new listing | 2026-06-03 |
| Latest new listing | 2026-06-24 |
| FDA registration number | 3005248192 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

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: 2026-10-28T20:51:27.468Z.
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.