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ImmuView S. pneumoniae and L. pneumophila urinary antigen test

FDA UDI

Class II (US FDA UDI)

by Ssi Diagnostica A/S

Identity

Trade Name
ImmuView S. pneumoniae and L. pneumophila urinary antigen test FDA UDI
Generic Name
Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Urinary antigen test FDA UDI
Model / Reference
2451 FDA UDI
Description
Urinary antigen test FDA UDI

Identifiers

Catalog Number
2451 FDA UDI
Primary DI / UDI-DI
05713106024515 FDA UDI
FDA Product Code
MJH FDA UDI
GWC FDA UDI
GMDN Term
Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3300 FDA UDI
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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical

ImmuView S. pneumoniae and L. pneumophila urinary antigen test by Ssi Diagnostica A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical.

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 2cf38c22-44d1-4bc3-b20f-f24c67828141 36 fields · synced Jun 1, 2026