FDA.reportPublic FDA data

PRO ADVANTAGE

Primary DI
M220P0800333
Brand
PRO ADVANTAGE
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
P080033
Catalog number
P080033
Device description
PRO ADVANTAGE A 25/BX
Published
2018-09-23
Public version status
Update
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
M220P0800335PackageHIBCC5In Commercial Distribution
M220P0800333PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A 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 A 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.

Contacts#

Phone, Email table
PhoneEmail
615-366-3230COMPLIANCE@NDC-INC.COM

Regulatory Flags#

DUNS number
009831413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M220P3010088Pro AdvantageP301008P3010082017-02-13
M220P3011058Pro AdvantageP301105P3011052017-02-13
M220P3011158Pro AdvantageP301115P3011152017-02-13
D023Q4000418QualaQ40004Q400042017-02-13
D023Q400042ML1QualaQ400042MLQ400042ML2017-04-25
D023Q400122ML19QualaQ400122MLQ400122ML2017-10-18
D023Q4003017QualaQ40030Q400302017-02-13
D23Q4001217QualaQ40012Q400122017-02-13
M2207250003Pro Advantage72000720002025-09-11
M220761002Pro Advantage76100761002025-09-11
M220762002Pro Advantage76200762002025-09-11
M220767000Pro Advantage76700767002025-09-11
M220768001Pro Advantage76800768002025-09-11
M220768011Pro Advantage76801768012025-09-11
M220769000Pro Advantage76900769002025-09-11
M220770001Pro Advantage77000770002025-09-11
M220771001Pro Advantage77100771002025-09-11
M220720005Pro Advantage72000720002025-09-11
M220761003Pro Advantage76100761002025-09-11
M220762003Pro Advantage76200762002025-09-11

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