Serono Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
What Serono Laboratories, Inc. makes
Serono Laboratories, Inc. manufactures radioimmunoassay (RIA) kits for measuring various hormones and biomarkers, including estradiol, estriol, progesterone, human placental lactogen, aldosterone, insulin, and neonatal T4, as well as glucose and Pap-check assays.
These devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Estradiol Ria Kit Ref K790679
510(k) 510(k)Estriol Radioimmunoassay Test Kit Ref K810695
510(k) 510(k)Pap-Check Ria Kit Ref K792043
510(k) 510(k)Progesterone Ref K790440
510(k) 510(k)Ria Kit, Preg-Stat Ref K781733
510(k) 510(k)Ria Kit, Neonatal T4 Ref K782103
510(k) 510(k)Human Placental Lactogen Radioimmuno- Ref K810625
510(k) 510(k)Aldosterone Radioimmunoassay Test Kit Ref K834428
510(k) 510(k)Ria Kit, Glucose Ref K782143
510(k) 510(k)Insulin Ria Kit Ref K781285
510(k) 510(k)
Frequently asked questions
How many devices does Serono Laboratories, Inc. have in the registry?
The registry currently lists 10 devices for Serono Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Serono Laboratories, Inc.'s devices?
Among its 10 most recently registered devices, Serono Laboratories, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Serono Laboratories, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Serono Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Serono Laboratories, Inc. in the registry?
The most recently registered devices listed for Serono Laboratories, Inc. include ESTRADIOL RIA KIT, ESTRIOL RADIOIMMUNOASSAY TEST KIT, PAP-CHECK RIA KIT and PROGESTERONE.