Data / Medical devices / Immunoassay, Pregnanediol Glucuronide, Over The Counter
Immunoassay, Pregnanediol Glucuronide, Over The Counter (QKE): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Immunoassay, Pregnanediol Glucuronide, Over The Counter (product code QKE, Class 1, 21 CFR 862.1620). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on February 27, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QKE
- Device class
- 1
- Regulation
- 862.1620
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 5 |
| Canada | 1 |
Makers of Immunoassay, Pregnanediol Glucuronide, Over The Counter
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 |
|---|---|---|---|---|---|---|---|---|
| MFB Fertility, Inc. | Boulder, CO, United States | Complaint file establishment, Specification developer | 1 | February 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eli Health | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genabio Diagnostics Inc | Bedford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Wondfo Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Careomedic Tech Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivd Research, LLC. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oova, Inc. | New York, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quanovate Tech Inc. | San Ramon, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 27, 2020. 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.