ImmuView S. pneumoniae and L. pneumophila urinary antigen test 10557

GUDID 05713106105573

Urinary antigen test

Ssi Diagnostica A/S

Multiple respiratory bacteria antigen IVD, kit, rapid ICT, clinical
Primary Device ID05713106105573
NIH Device Record Keyc4854936-cd0b-446e-807f-fcbe960bda08
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmuView S. pneumoniae and L. pneumophila urinary antigen test
Version Model Number10557
Catalog Number10557
Company DUNS305684449
Company NameSsi Diagnostica A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com
Phone+4548299100
Emailinfo@ssidiagnostica.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105713106105573 [Primary]

FDA Product Code

MJHLegionella, Spp., Elisa

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-02
Device Publish Date2022-10-25

On-Brand Devices [ImmuView S. pneumoniae and L. pneumophila urinary antigen test]

05713106024515Multiple respiratory bacteria antigen IVD, immunochromatographic test (ICT), rapid
05713106105573Urinary antigen test

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