ImmuView S. pneumoniae and L. pneumophila urinary antigen test

Primary DI
05713106024515
Brand
ImmuView S. pneumoniae and L. pneumophila urinary antigen test
Company
Ssi Diagnostica A/S
Model
2451
Catalog number
2451
Device description
Urinary antigen test
Published
2020-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWCANTISERA, ALL TYPES, STREPTOCOCCUS PNEUMONIAE
MJHLegionella, Spp., Elisa

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWCAntisera, All Types, Streptococcus PneumoniaeMicrobiology1
MJHLegionella, Spp., ElisaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191184000ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/S2020-03-05MJH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713106024515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713106024515057131060245155713106024515

GMDN Terms#

Term, Definition table
TermDefinition
Multiple respiratory bacteria antigen IVD, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple types of bacteria associated with respiratory disease (e.g., S. pneumoniae and L. pneumophila) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is typically used in the laboratory or in point-of-care analyses to aid in the diagnosis of pneumonia.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4548299100info@ssidiagnostica.com

Regulatory Flags#

DUNS number
305684449
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713106850046E. coli O8 serum, 1 mL85004850042021-08-11
05713106850053E. coli O9 serum, 1 mL85005850052021-08-11
05713106850237E. coli O26 serum, 1 mL85023850232021-08-11
05713106850428E. coli O45 serum, 1 mL85042850422021-08-11
05713106850831E. coli O88 serum, 1 mL85083850832021-08-11
05713106850978E. coli O103 serum, 1 mL85097850972021-08-11
05713106850985E. coli O104 serum, 1 mL85098850982021-08-11
05713106851074E. coli O111 serum, 1 mL85107851072021-08-11
05713106851180E. coli O121 serum, 1 mL85118851182021-08-11
05713106851357E. coli O139 serum, 1 mL85135851352021-08-11
05713106851371E. coli O141 serum, 1 mL85137851372021-08-11
05713106851418E. coli O145 serum, 1 mL85141851412021-08-11
05713106851456E. coli O149 serum, 1 mL85145851452021-08-11
05713106851531E. coli O157 serum, 1 mL85153851532021-08-11
05713106457405E. coli O1 serum, 3 mL45740457402021-08-02
05713106457412E. coli O2 serum, 3 mL45741457412021-08-02
05713106457443E. coli O5 serum, 3 mL45744457442021-08-02
05713106457450E. coli O6 serum, 3 mL45745457452021-08-02
05713106457948E. coli O55 serum, 3 mL45794457942021-08-02
05713106458150E. coli O78 serum, 3 mL45815458152021-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840239056450Legionella pneumophila IgG ELISADRG International IncMJH2023-08-25
05032384013227LEGIONELLA SPECIES TEST KITOXOID LIMITEDMJH2022-12-08
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SGWC2022-10-25
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SMJH2022-10-25
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05713106732656ImmuLex Streptococcus Group Kit, 6 x 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106732663Pneumococcus Factor 6d serum, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768549Pneumococcus Type 1 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768563Pneumococcus Type 2 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768587Pneumococcus Type 3 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768594Pneumococcus Type 4 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768648Pneumococcus Type 5 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768662Pneumococcus Type 8 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768679Pneumococcus Type 14 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768693Pneumococcus Type 20 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768716Pneumococcus Group 6 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768730Pneumococcus Group 7 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768778Pneumococcus Group 10 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768822Pneumococcus Group 11 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769119Pneumococcus Group 12 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769133Pneumococcus Group 15 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769140Pneumococcus Group 17 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769157Pneumococcus Group 18 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769164Pneumococcus Group 33 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769171Pneumococcus Factor 6b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769188Pneumococcus Factor 7b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769201Pneumococcus Factor 9d serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769218Pneumococcus Factor 9e serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769232Pneumococcus Factor 19b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01