FDA.reportPublic FDA data

MEDLINE

Primary DI
30888277191888
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MPH30025SA
Catalog number
MPH30025SA
Device description
TEST,STREP A,DIPSTICK,25 TEST
Published
2023-12-18
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
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
30888277191888PackageGS125In Commercial Distribution
40888277191885PackageGS140In Commercial Distribution
10888277191884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088827719188830888277191888
4088827719188540888277191885
1088827719188410888277191884

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Streptococcus bacterial species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of Streptococcus bacteria, or other similar gram positive, catalase negative cocci isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep dry and out of direct sunlight
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
25
HCT/P
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884389177686MEDLINEMDSMPHS4MDSMPHS42021-04-23
10080196415397MEDLINEMSC97412MSC974122026-05-27
10653160393634MEDLINEDYNDV2733ADYNDV2733A2026-05-27
10653160393665MEDLINEDYNDV2772DYNDV27722026-05-27
10653160393689MEDLINEDYNDV2787DYNDV27872026-05-27
10653160393702MEDLINEDYNDV2783DYNDV27832026-05-27
10653160393719MEDLINEDYNDV2797DYNDV27972026-05-27
10653160393726MEDLINEDYNDC2483ADYNDC2483A2026-05-27
10653160393733MEDLINEDT22665ADT22665A2026-05-27
10888277415386MEDLINEMSC97410MSC974102026-05-27
10888277415393MEDLINEMSC9748MSC97482026-05-27
10888277677289MEDLINEMSC97414MSC974142026-05-27
10888277677296MEDLINEMSC9746MSC97462026-05-27
10888277177680MEDLINEMDSMR117MDSMR1172021-05-14
10884389120620MEDLINEMDSMR112MDSMR1122021-04-23
10884389120675MEDLINEMDSMPHS2MDSMPHS22021-04-23
10884389128756MEDLINEMDSMR113MDSMR1132021-04-23
10884389177679MEDLINEMDSMPHS1MDSMPHS12021-04-23
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19

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