Response Biomedical Corp
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Response Biomedical Corp is a medical device manufacturer, with 27 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU IVD General and Class A) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 27
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 16
- EUDAMED 7
- FDA 510(k) 7
- Device classes
- FDA Class II 10
- FDA Class I 7
- EU IVD General 4
- EU Class A 1
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Response Biomedical Corp. Canada
- Identifiers
- DUNS 248609018
At a glance
Market reach
- United States
- FDA recalls
What Response Biomedical Corp makes
Response Biomedical Corp manufactures in vitro diagnostic (IVD) devices for cardiac and respiratory testing, including rapid immunoassay kits for troponin I, myoglobin, CK-MB, and NT-proBNP, as well as controls and fluorescent immunoassay analysers for point-of-care use. Their products also cover RSV antigen detection kits and controls, designed for clinical and rapid diagnostic applications. The company produces battery-powered analysers alongside single-use test kits for immediate results in healthcare settings.
The company’s portfolio is classified under Class I devices in the US, regulated by the FDA’s UDI (Unique Device Identification) system. These products are intended for in vitro diagnostic use, including cardiac markers, respiratory virus detection, and point-of-care testing.
Catalogue
Search and filter all 27 devicesCompany details
- DUNS number
- 248609018
- Phone
- +1.888.525.7267
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 15 Mar 2019 Z-1461-2020 Class II Terminated The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
Full distribution text
- 15 Mar 2019 Z-1461-2020 Class II Terminated The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
Sites
- Response Biomedical Corp. CAFEI 3004205692 12 devices
Frequently asked questions
How many devices does Response Biomedical Corp have in the registry?
The registry currently lists 27 devices for Response Biomedical Corp. Devices recorded under merged duplicate company entries are counted once.
Which registries list Response Biomedical Corp's devices?
Among its 27 most recently registered devices, Response Biomedical Corp has devices listed in EUDAMED (7 devices), FDA 510(k) (7 devices) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Response Biomedical Corp's devices fall under?
Among its 27 most recently registered devices, the classes recorded for Response Biomedical Corp's devices are Class I, Class II, IVDR Class A and IVD general. Each device page shows its own class and authorisation.
Are there FDA recall records for Response Biomedical Corp?
FDA recall records list 1 recall initiated by Response Biomedical Corp, the most recent initiated on 15 Mar 2019. 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 Response Biomedical Corp in the registry?
The most recently registered devices listed for Response Biomedical Corp include RAMP D-dimer, RAMP Total b-hCG, RAMP Total b-hCG Controls Level 2 and RAMP Total b-hCG Controls Level 1.