Ssi Diagnostica A/S

Address:2 Herredsvejen,Hilleroed Hovedstaden,DK

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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

ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE (GWC) (10)

Premarket Exempt

No Yes

Clear

ImmuLex Pneumococcus Factor 25b, 1.5 mL - 05713106989272 Catalog Number : 98927

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcus Factor 15h, 1.5 mL - 05713106989289 Catalog Number : 98928

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcus Factor 15e, 1.5 mL - 05713106989296 Catalog Number : 98929

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcus Factor 15c, 1.5 mL - 05713106989302 Catalog Number : 98930

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcus Factor 15b, 1.5 mL - 05713106989319 Catalog Number : 98931

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex S. pneumoniae Type 38, 1.5 mL - 05713106989326 Catalog Number : 98932

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Pneumococcus Factor 6b serum high titer, 1 mL - 05713106990179 Catalog Number : 99017

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Pneumococcus Factor 6c serum high titer, 1 mL - 05713106990186 Catalog Number : 99018

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Pneumococcus Factor 7b serum high titer, 1 mL - 05713106990209 Catalog Number : 99020

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Pneumococcus Factor 9d serum high titer, 1 mL - 05713106990216 Catalog Number : 99021

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

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