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, Rheumatoid Factor (DHR) (3) System, Test, Radioallergosorbent (Rast) Immunological (DHB) (2) Immunochemical, Thyroglobulin Autoantibody (JNL) (1) Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM) (1) Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (MLE) (1) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (1) Thyroglobulin, Antigen, Antiserum, Control (DDC) (1)

Premarket Exempt

No Yes

Clear

Hytec Specific IgE Reference Disc 100T MCS - 00081687902207 Catalog Number :

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

IgE Conjugate MCS - 00081687902221 Catalog Number :

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DHB

Prescription Use : No

Device Count : 1

Autostat II Anti-ds-DNA - 00816879020014 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LRM

Prescription Use : No

Device Count : 1

Autostat II Anti-Thyroglobulin - 00816879020038 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DDC

Prescription Use : No

Device Count : 1

Autostat II Anti-Thyroid Peroxidase - 00816879020045 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

Autostat II IgM Rheumatoid Factor - 00816879020052 Catalog Number :

Device Description : 96 well ELISA for the detection of IgM Rheumatoid Factor antibodies in human serum.

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

Autostat II IgA Rheumatoid Factor - 00816879020069 Catalog Number : FGA06

Device Description : 96 well ELISA for the detection of IgA Rheumatoid Factor antibodies in human serum.

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Autostat II IgG Rheumatoid Factor - 00816879020076 Catalog Number :

Device Description : 96 well ELISA for the detection of IgG Rheumatoid factor in human serum.

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

Autostat II Anti-Gastric Parietal Cell - 00816879020106 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MLE

Prescription Use : No

Device Count : 1

Autostat II Anti-PR 3 - 00816879020113 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-PR 3 antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

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