FDA.report

Henry Schein

Primary DI
20304040053243
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007570
Catalog number
9007570
Device description
One Step Pro Strep A Cassette
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Product Code Classifications

CodeDeviceSpecialtyClass
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20304040053243PackageGS115In Commercial Distribution
10304040053246PrimaryGS10
00304040053249Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404005324320304040053243
1030404005324610304040053246
00304040053249003040400532493040400532490304040053249

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10612479281575McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
10612479281582McKessonMCKESSON MEDICAL-SURGICAL INC.GTY2026-02-06
20810107290143Flowflex Plus Strep A Rapid Test CassetteAcon Laboratories, Inc.GTY2025-12-01
00810107290187Flowflex Plus Strep A Rapid Test StripAcon Laboratories, Inc.GTY2025-12-01
00722066010754Rapid ResponseBTNX IncGTY2025-05-29
30888277191888MedlineMEDLINE INDUSTRIES, INC.GTY2023-12-18
00722066006849Rapid ResponseBTNX IncGTY2023-08-14
10816862023722PreviewWONDFO USA CO., LTD.GTY2023-08-03
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
10885380183621CARDINAL HEALTHCardinal Health 200, LLCGTY2022-08-29
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
05713106821824S. pneumoniae reference strain 6CSsi Diagnostica A/SGTY2021-08-01
05713106821831S. pneumoniae reference strain 7FSsi Diagnostica A/SGTY2021-08-01
05713106821848S. pneumoniae reference strain 7ASsi Diagnostica A/SGTY2021-08-01
05713106821855S. pneumoniae reference strain 7BSsi Diagnostica A/SGTY2021-08-01
05713106821862S. pneumoniae reference strain 7CSsi Diagnostica A/SGTY2021-08-01
05713106821879S. pneumoniae reference strain 8Ssi Diagnostica A/SGTY2021-08-01
05713106821886S. pneumoniae reference strain 9ASsi Diagnostica A/SGTY2021-08-01
05713106821893S. pneumoniae reference strain 9LSsi Diagnostica A/SGTY2021-08-01
05713106821909S. pneumoniae reference strain 9NSsi Diagnostica A/SGTY2021-08-01