HYCOR BIOMEDICAL LLC

Address:7272 Chapman Ave,GARDEN GROVE,CA,92841,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Test, Anticardiolipin Immunological (MID) (3) Antibodies, Gliadin (MST) (2) Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) (MVJ) (1) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (MSV) (1) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (1) Test, Screening, For D Positive Fetal Rbc'S (LIM) (1)

Premarket Exempt

No Yes

Clear

Autostat II Anti-MPO - 00816879020120 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-MPO antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

Autostat II Anti-GBM - 00816879020137 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-GBM antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MVJ

Prescription Use : No

Device Count : 1

Autostat II ENA-6 Screen - 00816879020144 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-ENA antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

Autostat II Anti-Cardiolipin IgG - 00816879020151 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-Cardiolipin IgG antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Autostat II Anti-Cardiolipin IgM - 00816879020168 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-Cardiolipin IgM antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Autostat II Anti-Cardiolipin Screen - 00816879020182 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-cardiolipin antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1

Autostat II Anti-Gliadin IgG - 00816879020199 Catalog Number :

Device Description : 96 well ELISA for the detection of IgG Gliadin antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MST

Prescription Use : No

Device Count : 1

Autostat II Anti-Gliadin IgA - 00816879020205 Catalog Number :

Device Description : 96 well ELISA for the detection of IgA Gliadin antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MST

Prescription Use : No

Device Count : 1

Autostat II Anti-Nuclear Antibody (ANA) Screen - 00816879020212 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-nuclear antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LIM

Prescription Use : No

Device Count : 1

Autostat II Anti-B2-Glycoprotein I IgG - 00816879020229 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MSV

Prescription Use : No

Device Count : 1

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