Calbiotech Inc
El Cajon, CA, US
CALBIOTECH, INC. appears in FDA device records in El Cajon, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2090110 | 3002346973 | CALBIOTECH, INC. | 1935 Cordell Ct, El Cajon, CA 92020 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LSEEpstein-Barr Virus, Other
- LLLExtractable Antinuclear Antibody, Antigen And Control
- PPMGeneral Purpose Reagent
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- MVUReagents, Specific, Analyte
- JZOSystem, Test, Thyroid Autoantibody
- DJCThin Layer Chromatography, Methamphetamine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1004-2010 | VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-1003-2010 | VZV IgG ELISA 96 Well Kit, Catalog Number: VZ081G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-1002-2012 | Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-1001-2010 | Measles IgM ELISA 96 Well Kit, Catalog Number: MS019M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-1000-2010 | Measles IgG ELISA 96 Well Kit, Catalog Number: MS018G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0999-2010 | Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0998-2010 | Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0997-2010 | Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0996-2010 | H. Pylori IgM ELISA 96 Well Kit, Catalog Number: HP015M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0995-2010 | H. Pylori IgA ELISA 96 Well Kit, Catalog Number: HP014A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0994-2010 | EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0993-2010 | EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0992-2010 | Dengue IgM ELISA 96 Well Kit, Catalog Number: DE051M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0991-2010 | Dengue IgG ELISA 96 Well Kit, Catalog Number: DE050G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0990-2010 | dsDNA IgG ELISA 96 Well Kit, Catalog Number: DD037G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0989-2010 | Chlamydia Trachomatis IgA ELISA 96 Well Kit, Catalog Number: CT056A The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0988-2010 | Chlamydia Trachomatis IgM ELISA 96 Well Kit, Catalog Number: CT055M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0987-2010 | Chlamydia Trachomatis IgG ELISA 96 Well Kit, Catalog Number: CT054G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0986-2010 | Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0985-2010 | Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0984-2010 | Cardiolipin IgM ELISA 96 Well Kit, Catalog Number: CA036M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0983-2010 | Brucella IgM ELISA 96 Well Kit, Catalog Number: BA053M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0982-2010 | Brucella IgG ELISA 96 Well Kit, Catalog Number: BA052G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated | ||
| Z-0981-2010 | ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. | The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. The firm reported although there is no potential health hazard related to this recall, the recall was initiated because Calbiotech is fully committed to compliance with all State and Federal regulations. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain