Biocell Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Biocell Laboratories, Inc. makes
Biocell Laboratories, Inc. manufactures diagnostic control products for lipid analysis, including BIO-LIPID Lipid Control kits for monitoring cholesterol levels (Levels 1, 2, and 3), as well as calibrators for HDL and LDL measurement. The company also produces spinal fluid and cerebrospinal fluid (CSF) control products, such as the BIOCELL Spinal Fluid Control and BIO-CSF Liquid Control (Levels 1 and 2). Additionally, it supplies radial immunodiffusion plates for quantitative protein analysis and reference serum products, including the GEMCAL ENI Reference Serum for laboratory testing.
The company’s diagnostic controls and calibrators are classified under FDA’s Class I and Class II regulatory categories, with relevant devices authorised via the 510(k) pathway. These products are intended for use in clinical laboratories and are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Bio-Lipid Lipid Control- Level 1, 2 And 3 Ref K951749
Regimes: 510(k) Registry: 510(k)Biocell Spinal Fluid Control Ref K830179
Regimes: 510(k) Registry: 510(k)Bio-Csf Liquid Control Level 1 And 2 Ref K963551
Regimes: 510(k) Registry: 510(k)Radial Immunodiffusion Plates Ref K830911
Regimes: 510(k) Registry: 510(k)Bio-Lipid Human Serum Hdl And Ldl Calibrators Ref K000056
Regimes: 510(k) Registry: 510(k)Gemcal Eni Reference Serum Ref K844344
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocell Laboratories, Inc. have in the registry?
The registry currently lists 6 devices for Biocell Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocell Laboratories, Inc.'s devices?
Among its 6 most recently registered devices, Biocell Laboratories, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biocell Laboratories, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biocell 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 Biocell Laboratories, Inc. in the registry?
The most recently registered devices listed for Biocell Laboratories, Inc. include BIO-LIPID LIPID CONTROL- LEVEL 1, 2 AND 3, BIOCELL SPINAL FLUID CONTROL, BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 and RADIAL IMMUNODIFFUSION PLATES.