Data / Medical devices / Material, Quality Control, Semen Analysis
Material, Quality Control, Semen Analysis (NRF): 10 FDA-registered makers in 5 countries
10 establishments in 5 countries are registered with the FDA to make Material, Quality Control, Semen Analysis (product code NRF, Class 2, 21 CFR 864.8625). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on October 29, 2004, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NRF
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Israel | 1 |
| Taiwan | 1 |
| Turkey | 1 |
Makers of Material, Quality Control, Semen Analysis
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Electronic Systems Ltd. | CAESAREA IND. PARK Haifa, Israel | Manufacturer | 1 | July 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Manufacturer | 1 | June 2, 2004 | 0 | 0 | 0 | api.fda.gov |
| Bonraybio Co., Ltd. | Taichung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Merydi Bio-Tech Co., Ltd. | changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Wancheng Bio-Electron Co., Ltd. | Changchun Jilin, China | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fertility Solutions, Inc. | Warrensville Heights, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HAMILTON THORNE, Inc. | Beverly, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Hongyi Bio-Tech Co., Ltd. | Changchun Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yeni Biyoteknoloji Anonim Sirketi | BALCOVA Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 29, 2004. 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.