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) (6) ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. (GTY) (1) Antisera, All Groups, Salmonella Spp. (GRM) (1) Antisera, All Types, H. Influenza (GRP) (1) Legionella, Spp., Elisa (MJH) (1) Reagents, specific, analyte (MVU) (1)

Premarket Exempt

No Yes

Clear

Pneumococcus Omni serum, 1 mL - 05713106024386 Catalog Number : 2438

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

ImmuView S. pneumoniae and L. pneumophila urinary antigen test - 05713106024515 Catalog Number : 2451

Device Description : Urinary antigen test

Device Class : 1

Duns Number: 305684449

Premarket Exempt : No

Product Code : MJH, GWC

Prescription Use : Yes

Device Count : 1

Pneumococcus CWPS, 10 mg - 05713106034590 Catalog Number : 3459

Device Description : Cell wall polysaccharide

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

H. influenzae Type b serum, 1 mL - 05713106034620 Catalog Number : 3462

Device Description : Rabbit antisera. Ready-To-Use.

Device Class : 2

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GRP

Prescription Use : No

Device Count : 1

Pneumococcus Anti CWPS serum, 1 mL - 05713106036532 Catalog Number : 3653

Device Description : Rabbit antiserum, Ready to use

Device Class : 1

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GTY

Prescription Use : No

Device Count : 1

Salmonella monoclonal Vi serum, 3 mL - 05713106155141 Catalog Number : 15514

Device Description : Monoclonal antibody, Ready to use

Device Class : 2

Duns Number: 305684449

Premarket Exempt : Yes

Product Code : GRM

Prescription Use : No

Device Count : 1

Pneumococcus Pool A serum, 1 mL - 05713106167250 Catalog Number : 16725

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 Pool B serum, 1 mL - 05713106167281 Catalog Number : 16728

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 Pool C serum, 1 mL - 05713106167304 Catalog Number : 16730

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 Pool D serum, 1 mL - 05713106167311 Catalog Number : 16731

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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