Primus Corp.

Also registered as Primus, Inc.

United StatesFDA applicant, unverified

Primus Corp. is a medical device manufacturer, with 72 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 13 Nov 2026.

Devices: 72
FDA recalls: 1

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries: FDA GUDID 58
FDA 510(k) 14

A device listed in two registries counts in both.
Device classes: FDA Class II 70
FDA Class I 2
FDA recalls: 1 recall matched by name

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Primus Corp. makes

Primus Corp. manufactures in vitro diagnostic (IVD) reagents, analysers, kits, controls, and calibrators for measuring glycated haemoglobin (HbA1c) and detecting multiple haemoglobin subtypes. Their products include liquid chromatography-based kits for inherited haemoglobinopathy testing and HbA1c analysers designed for clinical laboratory use.

The company’s portfolio includes Class I and Class II devices, regulated under FDA pathways such as 510(k) premarket notifications and the UDI system.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue72

Newest first, rows 1-50 of 72

Search and filter all 72 devices

Rows 1-50 of 72

Showing 1-50 of 72

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Primus Corp., initiated on 2020-10-09. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 1
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2020
- 9 Oct 2020 Z-0321-2021 Class II Terminated The product did not receive pre-market approval or clearance. Distribution: US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan,…
  Full distribution text
  US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin OUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vietnam
  Submission number: K955283

Frequently asked questions

How many devices does Primus Corp. have in the registry?

The registry currently lists 72 devices for Primus Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Primus Corp.'s devices?

Among its 50 most recently registered devices, Primus Corp. has devices listed in FDA GUDID (50 devices).

What risk classes do Primus Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Primus Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Primus Corp.?

FDA recall records list 1 recall initiated by Primus Corp., the most recent initiated on 9 Oct 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Primus Corp. in the registry?

The most recently registered devices listed for Primus Corp. include Trinity Biotech Ultra2 Affinity A1c 3000, Trinity Biotech, Trinity Biotech Ultra2 Genesys Variants Analyzer and Trinity Biotech Premier Buffer B Reagent - 3.8L.

Generated automatically from registry data and not verified by a human reviewer.