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) (9) Antisera, All Groups, Salmonella Spp. (GRM) (1)

Premarket Exempt

No Yes

Clear

Pneumococcus Factor 12b serum high titer, 1 mL - 05713106968390 Catalog Number : 96839

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 15h serum high titer, 1 mL - 05713106968406 Catalog Number : 96840

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 17b serum high titer, 1 mL - 05713106968413 Catalog Number : 96841

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 15e serum high titer, 1 mL - 05713106968444 Catalog Number : 96844

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcus Factor 6d, 1.5 mL - 05713106969762 Catalog Number : 96976

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 15b serum high titer, 1 mL - 05713106971741 Catalog Number : 97174

Device Description : Rabbit antiserum, High titer

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GWC

Prescription Use : No

Device Count : 1

Salm. Multi Gr. Poly A-67 serum, 3 mL - 05713106982464 Catalog Number : 98246

Device Description : Serological Conf., Rabbit antiserum, Ready to use

Device Class : 2

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GRM

Prescription Use : No

Device Count : 1

ImmuLex Pneumococcuc Factor 9e, 1,5 mL - 05713106988855 Catalog Number : 98885

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 Pneumokok Group 25, 1,5 mL - 05713106989258 Catalog Number : 98925

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 25c, 1.5 mL - 05713106989265 Catalog Number : 98926

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

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