FDA.reportPublic FDA data

Streptococcus reference strain group B type IX

Primary DI
05713106849101
Brand
Streptococcus reference strain group B type IX
Company
Ssi Diagnostica A/S
Model
84910
Catalog number
84910
Device description
Reference strain
Published
2021-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713106849101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713106849101057131068491015713106849101

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Streptococcus species antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple species of Streptococcus bacteria in a clinical specimen and/or culture isolate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305684449
Device count
1
Premarket exempt
true
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
20612479281558McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
20612479281565McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
10612479281575McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
10612479281582McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
00810107290132Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290156Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
20810107290143Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290187Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
10722066010751Rapid ResponseBTNX IncGTY2025-05-29
00722066010754Rapid ResponseBTNX IncGTY2025-05-29
30888277191888MEDLINEMEDLINE INDUSTRIES, INC.GTY2023-12-18
10722066006846Rapid ResponseBTNX IncGTY2023-08-14
00722066006849Rapid ResponseBTNX IncGTY2023-08-14
00816862023725PreviewWONDFO USA CO., LTD.GTY2023-08-03
10816862023722PreviewWONDFO USA CO., LTD.GTY2023-08-03
00695684755256StrepAimGERMAINE LABORATORIES, INCGTY2023-01-17
06974849369120Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369137Group B Streptococcus Detection Kit(Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369144Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
06974849369151Group A Streptococcus Antigen Detection Kit (Immunochromatography)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.GTY2022-12-06
20885380183628CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
10885380183621CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
00816862023589PreviewWONDFO USA CO., LTD.GTY2021-08-20
10816862023586PreviewWONDFO USA CO., LTD.GTY2021-08-20
05713106821756S. pneumoniae reference strain 1Ssi Diagnostica A/SGTY2021-08-01
05713106821763S. pneumoniae reference strain 2Ssi Diagnostica A/SGTY2021-08-01
05713106821770S. pneumoniae reference strain 3Ssi Diagnostica A/SGTY2021-08-01
05713106821787S. pneumoniae reference strain 4Ssi Diagnostica A/SGTY2021-08-01
05713106821794S. pneumoniae reference strain 5Ssi Diagnostica A/SGTY2021-08-01
05713106821800S. pneumoniae reference strain 6ASsi Diagnostica A/SGTY2021-08-01