THE BINDING SITE GROUP LIMITED

Address:8 Calthorpe Road,BIRMINGHAM,GB

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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, Nephelometric, Immunoglobulins (G, A, M) (CFN) (6) Igd, Antigen, Antiserum, Control (CZJ) (1) Kappa, Antigen, Antiserum, Control (DFH) (1) Lambda, Antigen, Antiserum, Control (DEH) (1)

Premarket Exempt

No Yes

Clear

Beckman Immage IgG3 Latex Kit - 05051700006149 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - 05051700006163 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - 05051700006170 Catalog Number :

Device Description : Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - Bulk Kit

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman Coulter AU® series - 05051700006187 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Hu IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Modular P - 05051700006217 Catalog Number :

Device Description : Human IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitach Human IgG4 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917 and Hitachi Modular P

Device Class :

Duns Number: 347045614

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Human IgG4 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 - 05051700006224 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II - 05051700006248 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CFN

Prescription Use : Yes

Device Count : 1

Human IgD Liquid Latex Reagent Kit for use on the Siemens BN™II - 05051700006255 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : CZJ

Prescription Use : Yes

Device Count : 1

Freelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit - 05051700006279 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : DFH

Prescription Use : Yes

Device Count : 1

Freelite® Human Kappa Free Kit for use on the Beckman AU® series - 05051700006286 Catalog Number :

Device Class : 2

Duns Number: 347045614

Premarket Exempt : No

Product Code : DEH

Prescription Use : Yes

Device Count : 1

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