FDA.reportPublic FDA data

Dealmed

Primary DI
00817415020963
Brand
Dealmed
Company
DEALMED MEDICAL SUPPLIES LLC
Model
788025
Catalog number
788025
Device description
Strep A Test CLIA Waived 25/Box
Published
2020-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00817415020963PrimaryGS10
00817415020307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817415020963008174150209638174150209630817415020963
00817415020307008174150203078174150203070817415020307

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group B Streptococcus antigen IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group B beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature35 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
068586441
Device count
25
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817415020086Dealmed7875307875302022-08-29
00859140003125Dealmed7875207875202022-08-29
10817415021653Dealmed7831327831322021-09-30
10817415021844DEALMED7838227838222021-09-17
00859140003750Dealmed8591400037577830432020-09-11
00859140003798Dealmed7838047838042020-12-04
00817415021861Dealmed7864017864012021-04-26
00817415021878Dealmed7864027864022021-04-26
00817415021885Dealmed7864037864032021-04-26
00817415023049Dealmed7864047864042022-07-18
00817415023087Dealmed7864087864082022-07-28
00817415023063Dealmed7864067864062022-07-28
00817415020468Dealmed7836197836192020-12-04
00817415020512Dealmed7835037835032020-12-04
00817415021069Dealmed7885257885252021-06-11
00817415022370Dealmed7832527832522022-08-29
00817415022387Dealmed7832537832532022-08-29
00817415022394Dealmed7832547832542022-08-29
00817415022400Dealmed8079458079452021-10-25
00817415021083Dealmed7830327830322020-12-04

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