BIO-RAD LABORATORIES, INC.

Address:4000 Alfred Nobel Drive,Hercules,CA,94547,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

ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL (DHN) (5) ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL (LKJ) (4) ANTI-SM ANTIBODY, ANTIGEN AND CONTROL (LKP) (1)

Premarket Exempt

No Yes

Clear

Liquichek - 00847661000105 Catalog Number : 111

Device Description : Liquichek ANA Control, Nucleolar Pattern, Positive (A pre-diluted human serum au Liquichek ANA Control, Nucleolar Pattern, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Liquichek - 00847661000112 Catalog Number : 112

Device Description : Liquichek ANA Control, Centromere Pattern, Positive (A pre-diluted human serum a Liquichek ANA Control, Centromere Pattern, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Liquichek - 00847661000129 Catalog Number : 118

Device Description : Liquichek ANA Control, Mitotic Spindle Pattern, Positive (A pre-diluted human se Liquichek ANA Control, Mitotic Spindle Pattern, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Liquichek - 00847661000136 Catalog Number : 113

Device Description : Liquichek Anti-SS-B Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : LKJ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000143 Catalog Number : 114

Device Description : Liquichek Anti-SS-A Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : LKJ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000150 Catalog Number : 115

Device Description : Liquichek Anti-Sm Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : LKP

Prescription Use : No

Device Count : 1

Liquichek - 00847661000167 Catalog Number : 116

Device Description : Liquichek Anti-RNP Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : LKJ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000174 Catalog Number : 117

Device Description : Liquichek Anti-Scl-70 Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : LKJ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000181 Catalog Number : 119

Device Description : Liquichek Anti-nDNA Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Liquichek - 00847661000198 Catalog Number : 127

Device Description : Liquichek Anti-Mitochondrial Control, Positive (A pre-diluted human serum autoim Liquichek Anti-Mitochondrial Control, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

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