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Pneumococcus Type 4 serum high titer, 1 mL

FDA UDI

Class I (US FDA UDI)

by Ssi Diagnostica A/S

Identity

Trade Name
Pneumococcus Type 4 serum high titer, 1 mL FDA UDI
Generic Name
Streptococcus pneumoniae culture isolate antigen IVD, antibody FDA UDI
Device Name
Rabbit antiserum, High titer FDA UDI
Model / Reference
76859 FDA UDI
Description
Rabbit antiserum, High titer FDA UDI

Identifiers

Catalog Number
76859 FDA UDI
Primary DI / UDI-DI
05713106768594 FDA UDI
FDA Product Code
GWC FDA UDI
GMDN Term
Streptococcus pneumoniae culture isolate antigen IVD, antibody FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Streptococcus pneumoniae culture isolate antigen IVD, antibody

Pneumococcus Type 4 serum high titer, 1 mL by Ssi Diagnostica A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Streptococcus pneumoniae culture isolate antigen IVD, antibody.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ssi Diagnostica A/S

Sources (1)

  • FDA UDI c0eef791-82b9-4b09-8afe-a4c9386d48c0 36 fields · synced May 30, 2026