Genbio

Address:15222 AVE. OF SCIENCE,Rancho Bernardo,CA,92128,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

Immunochemical, Thyroglobulin Autoantibody (JNL) (2) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1)

Premarket Exempt

No Yes

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ImmunoDOT Autoimmunity Panel 4 - 00613745054896 Catalog Number : 5489

Device Description : The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : LLL

Prescription Use : No

Device Count : 1

ImmunoDOT Thyroid Autoimmunity Panel - 00613745058252 Catalog Number : 5825

Device Description : The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

ImmunoDOT Thyroid Autoimmunity Panel - 00613745058894 Catalog Number : 5889

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

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