MedtechSourcebook

CALBIOTECH, INC.

Contract manufacturer · El Cajon, CA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
2090110 (openFDA record; or search FDA's registration database)
FEI number
3002346973
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Calbiotech, Inc. (FDA owner/operator no. 9046880)
Registered address
1935 Cordell Ct, El Cajon, CA 92020
Contract listings
15 device listings, 10 product codes, first listed Nov 16, 2006
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
JZOSystem, Test, Thyroid AutoantibodyClass IIImmunologyContract manufacturingSep 16, 2024
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusClass IIMicrobiologyContract manufacturingApr 4, 2023
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificClass IIMicrobiologyContract manufacturingApr 4, 2023
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiClass IIMicrobiologyContract manufacturingSep 16, 2024
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggClass IMicrobiologyContract manufacturingSep 16, 2024
LJYEnzyme Linked Immunoabsorbent Assay, Mumps VirusClass IMicrobiologyContract manufacturingJun 5, 2024
LLLExtractable Antinuclear Antibody, Antigen And ControlClass IIImmunologyContract manufacturingApr 4, 2023
LSEEpstein-Barr Virus, OtherClass IMicrobiologyContract manufacturingApr 4, 2023
MVUReagents, Specific, AnalyteClass IPathologyContract manufacturingNov 17, 2006
PPMGeneral Purpose ReagentClass IPathologyContract manufacturingNov 16, 2006