# Nanoentek America, Inc (other, North Waltham, MA): 3 new FDA device listings, incl. radioimmunoassay, total triiodothyronine

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Nanoentek America, Inc |
| Owner / operator | NanoEntek, Inc |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | North Waltham, MA, US |
| New listings | 3 |
| Devices | Radioimmunoassay, Total Triiodothyronine; Multi-Analyte Controls, All Kinds (Assayed); Counter, Differential Cell |
| Product codes | CDP, JJY, GKZ |
| Device classes | Class I, Class II |
| Medical specialties | Clinical Chemistry, Hematology |
| Brand names | FREND Free T3; FREND ImmunoAssay Multi; ADAMII CD34 System |
| First new listing | 2026-06-29 |
| Latest new listing | 2026-07-27 |
| FDA registration number | 3007113174 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- 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: 2026-11-04T21:52:36.524Z.
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.