FDA.reportPublic FDA data

DiaSpect Control Pack HBT3

Primary DI
04048534001571
Brand
DiaSpect Control Pack HBT3
Company
DiaSpect Medical GmbH
Model
90B.0013
Device description
For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04048534001571PrimaryGS10
04048534001724Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048534001571040485340015714048534001571
04048534001724040485340017244048534001724

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
Special Storage Condition, Specify00Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4939203511414support@ekf-diagnostic.de
1-800-531-5535techsupport@ekfdiagnostics.com

Regulatory Flags#

DUNS number
341050309
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048534001540DiaSpect Hemoglobin Cuvettes90C.00012022-12-20
04048534001557DiaSpect Control Pack HBT190B.00112022-12-20
04048534001564DiaSpect Control Pack HBT290B.00122022-12-20
04048534001588DiaSpect Control Pack HBT490B.00142022-12-20

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
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
03610522141975LiquichekBIO-RAD LABORATORIES, INC.GGM2021-08-27