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

Pneumococcus Factor 9e serum high titer, 1 mL - 05713106990322 Catalog Number : 99032

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 9g serum high titer, 1 mL - 05713106990339 Catalog Number : 99033

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 19b serum high titer, 1 mL - 05713106990346 Catalog Number : 99034

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 19c serum high titer, 1 mL - 05713106990353 Catalog Number : 99035

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 22b serum high titer, 1 mL - 05713106990360 Catalog Number : 99036

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 23b serum high titer, 1 mL - 05713106990377 Catalog Number : 99037

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 18c serum high titer, 1 mL - 05713106992104 Catalog Number : 99210

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 33b serum high titer, 1 mL - 05713106993040 Catalog Number : 99304

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 11c serum high titer, 1 mL - 05713106993064 Catalog Number : 99306

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 12b serum high titer, 1 mL - 05713106993071 Catalog Number : 99307

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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