KRONUS, INC.

Address:170 S. Seneca Springs Way,Star,ID,83669,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

Aquaporin-4 Autoantibody (PNI) (1) Autoantibodies, Glutamic Acid Decarboxylase (Gad) (NWG) (1) Tyrosine Phosphatase (Ia-2) Autoantibody Assay (OIF) (1) Zinc Transporter 8 Auto-Antibody (PHF) (1)

Premarket Exempt

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KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT - B126KR77100 Catalog Number : KR7710

Device Description : An enzyme linked immunosorbent assay for the semi-quantitative determination of An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.

Device Class : 2

Duns Number: 181070814

Premarket Exempt : No

Product Code : NWG

Prescription Use : No

Device Count : 1

Zinc Transporter 8 Auto-Antibody (ZnT8) - B126KR77300 Catalog Number : KR7730

Device Description : An enzyme linked immunosorbent assay for the semi-quantitative determination of An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.

Device Class : 2

Duns Number: 181070814

Premarket Exempt : No

Product Code : PHF

Prescription Use : No

Device Count : 1

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit - B126KR77550 Catalog Number : KR7755

Device Description : An enzyme linked immunosorbent assay for the quantitative determination of autoa An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum

Device Class : 2

Duns Number: 181070814

Premarket Exempt : No

Product Code : OIF

Prescription Use : Yes

Device Count : 1

Aquaporin-4 Auto-Antibody (AQP4Ab) - B126KR82000 Catalog Number : KR8200

Device Class : 2

Duns Number: 181070814

Premarket Exempt : No

Product Code : PNI

Prescription Use : Yes

Device Count : 1

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