ImmuView S. pneumoniae and L. pneumophila urinary antigen test 2451

GUDID 05713106024515

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

Ssi Diagnostica A/S

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Primary Device ID05713106024515
NIH Device Record Key2cf38c22-44d1-4bc3-b20f-f24c67828141
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmuView S. pneumoniae and L. pneumophila urinary antigen test
Version Model Number2451
Catalog Number2451
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 Perscriptionfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105713106024515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-04-01
Device Publish Date2020-03-24

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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