ClearanceBrief
Company

Calbiotech Inc

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.3
MGMC. Trachomatis (Chlamydia Group)3
GSMAntisera, Fluorescent, Brucella Spp.2
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg2
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)2
LYRHelicobacter Pylori2
NWYTest, Qualitative, Detection Of Dengue Igm And Igg Antibodies2
GQXAntiserum, Cf, Varicella-Zoster1
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster1
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii1
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls1
LJYEnzyme Linked Immunoabsorbent Assay, Mumps Virus1
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control1
LSEEpstein-Barr Virus, Other1
MIDSystem, Test, Anticardiolipin Immunological1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 5, 2010Calbiotech Inc
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.
Terminated
GQXNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LFYNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LGDNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJBNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJBNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJYNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJZNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJZNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LYRNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LYRNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LSENone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJZNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
NWYNone listed
Mar 5, 2010Calbiotech Inc
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
Terminated
NWYNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LRMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
MGMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
MGMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
MGMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJCNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJCNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
MIDNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
GSMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
GSMNone listed
Mar 5, 2010Calbiotech Inc
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.
Terminated
LJMNone listed
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