ANTIBODIES INCORPORATED

Address:25242 COUNTY ROAD 95,DAVIS,CA,95616,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) (4)

Premarket Exempt

No Yes

Clear

ANA Test Kit - 10862534000300 Catalog Number : 15-112

Device Description : Antinuclear Antibody (ANA) Test Kit

Device Class : 2

Duns Number: 048944128

Premarket Exempt : Yes

Product Code : DHN

Prescription Use : No

Device Count : 1

ANA Test Kit - 10862534000317 Catalog Number : 15-113

Device Description : Antinuclear Antibody (ANA) Test Kit

Device Class : 2

Duns Number: 048944128

Premarket Exempt : Yes

Product Code : DHN

Prescription Use : No

Device Count : 1

ANA Test Kit - 10862534000324 Catalog Number : 15-123

Device Description : Antinuclear Antibody (ANA) Test Kit

Device Class : 2

Duns Number: 048944128

Premarket Exempt : Yes

Product Code : DHN

Prescription Use : No

Device Count : 1

nDNA Test Kit - 10862534000331 Catalog Number : 15-211

Device Description : Anti-nDNA Antibody Test Kit

Device Class : 2

Duns Number: 048944128

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

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