KENT LABORATORIES INC

Address:777 Jorgensen Pl,BELLINGHAM,WA,98226,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

Method, Immunodiffusion, Immunoglobulins (G, A, M) (CGM) (2) Iga, Fitc, Antigen, Antiserum, Control (CZN) (1) Iga, Rhodamine, Antigen, Antiserum, Control (CZK) (1) Igg, Antigen, Antiserum, Control (DEW) (1) Igg, Fitc, Antigen, Antiserum, Control (DGK) (1) Igg, Peroxidase, Antigen, Antiserum, Control (DAA) (1) Igg, Rhodamine, Antigen, Antiserum, Control (DFO) (1) Iga, Antigen, Antiserum, Control (CZP) (1) Whole Human Serum, Antigen, Antiserum, Control (DGR) (1)

Premarket Exempt

No Yes

Clear

Antiserum to Whole Human Serum - B1761000 Catalog Number : 100002

Device Description : Goat antiserum to Whole Human Serum

Device Class : 1

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DGR

Prescription Use : No

Device Count : 1

Antiserum to Human IgG (gamma chain specific) - B1761010 Catalog Number : 101002

Device Description : Goat antiserum to Human IgG

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DEW

Prescription Use : No

Device Count : 1

Rhodamine conjugated antiserum to Human IgG - B1761011 Catalog Number : 101102

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DFO

Prescription Use : No

Device Count : 1

Anti Human IgG FITC - B1761012 Catalog Number : 101202

Device Description : Fluorescein Conjugated Antiserum to Human IgG

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DGK

Prescription Use : No

Device Count : 1

IgG RID Plate Package - B1761014 Catalog Number : 101411

Device Description : Radial immunodiffusion plate package for human IgG

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CGM

Prescription Use : No

Device Count : 1

IgG RID Plate Kit - B1761015 Catalog Number : 101511

Device Description : Radial immunodiffusion plate package for human human IgG with three standards

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CGM

Prescription Use : No

Device Count : 1

Peroxidase conjugated Antiserum to Human IgG - B1761018 Catalog Number : 101872

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DAA

Prescription Use : No

Device Count : 1

Antiserum to Human IgA (alpha chain specific) - B1761020 Catalog Number : 102002

Device Description : Goat antiserum to Human IgA

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CZP

Prescription Use : No

Device Count : 1

Rhodamine conjugated antiserum to Human IgA - B1761021 Catalog Number : 1021002

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CZK

Prescription Use : No

Device Count : 1

Anti Human IgA FITC - B1761022 Catalog Number : 102202

Device Description : Fluorescein conjugated polyclonal goat antiserum to Human IgA

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CZN

Prescription Use : No

Device Count : 1

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