HYCOR BIOMEDICAL LLC

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

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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

Extractable Antinuclear Antibody, Antigen And Control (LLL) (4) Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM) (2) System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (MSV) (2) Anti-Rnp Antibody, Antigen And Control (LKO) (1) Anti-Sm Antibody, Antigen And Control (LKP) (1)

Premarket Exempt

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Clear

Autostat II Anti-B2-Glycoprotein I IgM - 00816879020236 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MSV

Prescription Use : No

Device Count : 1

Autostat II Anti-B2-Glycoprotein I IgA - 00816879020243 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MSV

Prescription Use : No

Device Count : 1

Autostat II Anti-Tissue Transglutaminase IgA - 00816879020250 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-Tissue Transglutaminase IgA antibodies i 96 well ELISA for the detection of Anti-Tissue Transglutaminase IgA antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MVM

Prescription Use : No

Device Count : 1

Autostat II Anti-Tissue Transglutaminase IgG - 00816879020267 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : MVM

Prescription Use : No

Device Count : 1

Autostat II Anti-SS-A/Ro - 00816879020298 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-SS-A/Ro 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-SS-B/La - 00816879020304 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-SS-B/La 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-Sm - 00816879020311 Catalog Number :

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

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LKP

Prescription Use : No

Device Count : 1

Autostat II Anti-Sm/RNP - 00816879020328 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-Sm/RNP antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LKO

Prescription Use : No

Device Count : 1

Autostat II Anti-Jo-1 - 00816879020335 Catalog Number :

Device Description : 96 well ELISA for the detection of Anti-Jo-1 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-Scl-70 - 00816879020342 Catalog Number :

Device Description : 96 well ELISA for the detection of anti-Scl-70 antibodies in human serum

Device Class : 2

Duns Number: 010558476

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

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