Data / Medical devices / Dna Probe, Nucleic Acid Amplification, Chlamydia
Dna Probe, Nucleic Acid Amplification, Chlamydia (MKZ): 19 FDA-registered makers in 9 countries
19 establishments in 9 countries are registered with the FDA to make Dna Probe, Nucleic Acid Amplification, Chlamydia (product code MKZ, Class 1, 21 CFR 866.3120). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on November 16, 2023, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MKZ
- Device class
- 1
- Regulation
- 866.3120
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 1 |
| United Kingdom | 1 |
| Sweden | 1 |
| Italy | 1 |
| Canada | 1 |
| Malaysia | 1 |
| China | 1 |
| Switzerland | 1 |
Makers of Dna Probe, Nucleic Acid Amplification, Chlamydia
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | May 20, 2014 | 0 | 2 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 2 | November 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export, Specification developer | 1 | July 10, 2008 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer | 1 | July 10, 2008 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 1 | January 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer, Manufacturer for export | 1 | January 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | January 24, 2012 | 0 | 0 | 0 | api.fda.gov |
| Binx Health, Ltd. | Trowbridge Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Lodi, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Sdn. Bhd. | SENAI Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hochuen Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visby Medical, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.