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S. pneumoniae reference strain 36

FDA UDI

Class I (US FDA UDI)

by Ssi Diagnostica A/S

Identity

Trade Name
S. pneumoniae reference strain 36 FDA UDI
Generic Name
Streptococcus pneumoniae culture isolate antigen IVD, control FDA UDI
Device Name
Reference strain FDA UDI
Model / Reference
82251 FDA UDI
Description
Reference strain FDA UDI

Identifiers

Catalog Number
82251 FDA UDI
Primary DI / UDI-DI
05713106822517 FDA UDI
FDA Product Code
GTY FDA UDI
GMDN Term
Streptococcus pneumoniae culture isolate antigen IVD, control 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, control

S. pneumoniae reference strain 36 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, control.

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 be8292f2-ef05-4123-952e-c0d21748e7cb 36 fields · synced Jun 6, 2026