ImmuView S. pneumoniae and L. pneumophila urinary antigen test - Urinary antigen test - Ssi Diagnostica A/S

Duns Number:305684449

Device Description: Urinary antigen test

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More Product Details

Catalog Number

2451

Brand Name

ImmuView S. pneumoniae and L. pneumophila urinary antigen test

Version/Model Number

2451

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GWC

Product Code Name

ANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE

Device Record Status

Public Device Record Key

2cf38c22-44d1-4bc3-b20f-f24c67828141

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SSI DIAGNOSTICA A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1152
2 A medical device with a moderate to high risk that requires special controls. 272