FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040103804
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701313
Catalog number
5701313
Device description
OneStepTM + Pro Hb Controls
Published
2019-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GGMControl, hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGMControl, HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040103804PrimaryGS10
00304040103807Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404010380410304040103804
00304040103807003040401038073040401038070304040103807

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
012430880
Device count
3
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718734962649CueSee® CO-OXEurotrol B.V.GGM2025-01-23
08718734962656CueSee® CO-OXEurotrol B.V.GGM2025-01-23
06935740726993Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-09-20
06935740733830Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733847Hemoglobin Test StripUrit Medical Electronic Co., Ltd.GGM2024-07-12
06935740733854Hemoglobin Control SolutionUrit Medical Electronic Co., Ltd.GGM2024-07-12
04048534001557DiaSpect Control Pack HBT1DiaSpect Medical GmbHGGM2022-12-20
04048534001564DiaSpect Control Pack HBT2DiaSpect Medical GmbHGGM2022-12-20
04048534001571DiaSpect Control Pack HBT3DiaSpect Medical GmbHGGM2022-12-20
04048534001588DiaSpect Control Pack HBT4DiaSpect Medical GmbHGGM2022-12-20
08718734961024CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961048CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961550CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961567CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961574CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961581CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961598CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961000CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961062CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961079CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961086CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961604CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962397CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961611CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734962403CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961628CueSee® CO-OXEurotrol B.V.GGM2021-12-19
08718734961635CueSee® CO-OXEurotrol B.V.GGM2021-12-19
03610522141944LiquichekBIO-RAD LABORATORIES, INC.GGM2021-08-27
03610522141951LiquichekBIO-RAD LABORATORIES, INC.GGM2021-08-27
03610522141968LiquichekBIO-RAD LABORATORIES, INC.GGM2021-08-27