FDA.reportPublic FDA data

S. pneumoniae reference strain 2

Primary DI
05713106821763
Brand
S. pneumoniae reference strain 2
Company
Ssi Diagnostica A/S
Model
82176
Catalog number
82176
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
05713106821763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713106821763057131068217635713106821763

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus pneumoniae culture isolate antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from Streptococcus pneumoniae bacteria isolated by culture from a clinical specimen.

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
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
05713106821817S. pneumoniae reference strain 6BSsi Diagnostica A/SGTY2021-08-01