KENT LABORATORIES INC

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

Method, Immunodiffusion, Immunoglobulins (G, A, M) (CGM) (2) Plates And Equipment, Radial Immunodiffusion (JZQ) (2) Igm (Mu Chain Specific), Antigen, Antiserum, Control (DAO) (1) Igm, Fitc, Antigen, Antiserum, Control (DFS) (1) Iga, Peroxidase, Antigen, Antiserum, Control (CZL) (1) Igm, Rhodamine, Antigen, Antiserum, Control (DEZ) (1) Igm, Peroxidase, Antigen, Antiserum, Control (DEY) (1) Ige, Antigen, Antiserum, Control (DGC) (1)

Premarket Exempt

No Yes

Clear

IgA RID plate package - B1761024 Catalog Number : 102411

Device Description : Radial immunodiffusion plate package for human IgA

Device Class : 1

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : JZQ

Prescription Use : No

Device Count : 1

IgA RID plate Kit - B1761025 Catalog Number : 102511

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

Device Class : 1

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : JZQ

Prescription Use : No

Device Count : 1

Peroxidase conjugated antiserum to Human IgA - B1761028 Catalog Number : 102872

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CZL

Prescription Use : No

Device Count : 1

Antiserum to Human IgM (muc chain specific) - B1761030 Catalog Number : 103002

Device Description : Goat antiserum to Human IgM

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DAO

Prescription Use : No

Device Count : 1

Rhodamine conjugated antiserum to Human IgM - B1761031 Catalog Number : 103102

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DEZ

Prescription Use : No

Device Count : 1

Anti Human IgM FITC - B1761032 Catalog Number : 103202

Device Description : Fluorescein conjugated polyclonal goat antiserum to Human IgM

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DFS

Prescription Use : No

Device Count : 1

IgM RID plate package - B176103411 Catalog Number : 103411

Device Description : Radial immunodiffusion plate package for human IgM

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CGM

Prescription Use : No

Device Count : 1

IgM RID plate kit - B1761035 Catalog Number : 103511

Device Description : Radial immunodiffusion plate package for human IgM with standards

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : CGM

Prescription Use : No

Device Count : 1

Peroxidase conjugated antiserum to Human IgM - B1761038 Catalog Number : 103872

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DEY

Prescription Use : No

Device Count : 1

Antiserum to Human IgE (epsilon specific) - B1761040 Catalog Number : 104002

Device Description : Goat antiserum to Human IgE

Device Class : 2

Duns Number: 093642254

Premarket Exempt : Yes

Product Code : DGC

Prescription Use : No

Device Count : 1

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