Medical Specialties Laboratories
Country not established
- Devices
- 5
What Medical Specialties Laboratories makes
Medical Specialties Laboratories produces hematology control products, including the UNI-CELL series (5, 7, and 8) and UNI-CELL, which are used for instrument calibration and quality assurance in laboratory settings. They also manufacture NORMLCERA, a reference material for hematology analyzers, and UNI-PLATE, a control for platelet counting. Additionally, the company offers coagulation factor-deficient plasma for assessing coagulation assays.
The company’s portfolio includes Class I and Class II devices, with regulatory submissions recorded under the FDA’s 510(k) pathway. These products are intended for in vitro diagnostic use and are listed in the United States. The manufacturer is based in the US.
Catalogue
Hematology Control Uni-Cell 5, Uni-Cell 7 & 8 Ref K844897
Regimes: 510(k) Registry: 510(k)Uni-Cell Ref K823587
Regimes: 510(k) Registry: 510(k)Normlcera Ref K810268
Regimes: 510(k) Registry: 510(k)Uni-Plate Ref K852643
Regimes: 510(k) Registry: 510(k)Coagulation Factor Deficient Plasma Ref K840114
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medical Specialties Laboratories have in the registry?
The registry currently lists 5 devices for Medical Specialties Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Specialties Laboratories's devices?
Among its 5 most recently registered devices, Medical Specialties Laboratories has devices listed in FDA 510(k) (5 devices).
What risk classes do Medical Specialties Laboratories's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Medical Specialties Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medical Specialties Laboratories in the registry?
The most recently registered devices listed for Medical Specialties Laboratories include HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8, UNI-CELL, NORMLCERA and UNI-PLATE.