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Pneumococcus Factor 7b serum, 1 mL

FDA UDI

Class I (US FDA UDI)

by Ssi Diagnostica A/S

Identity

Trade Name
Pneumococcus Factor 7b serum, 1 mL FDA UDI
Generic Name
Streptococcus pneumoniae culture isolate antigen IVD, antibody FDA UDI
Device Name
Rabbit antiserum, Ready to use FDA UDI
Model / Reference
16925 FDA UDI
Description
Rabbit antiserum, Ready to use FDA UDI

Identifiers

Catalog Number
16925 FDA UDI
Primary DI / UDI-DI
05713106169254 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

The Pneumococcus Factor 7b serum, 1 mL, is a ready-to-use rabbit antiserum for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen. This device is labeled as not containing MRI Safety Information and is approved for in commercial distribution.

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 0584c39f-ae51-43b0-bd8e-68be4f41381a 36 fields · synced Oct 6, 2026