Home GUDID 04560189283671 Hemoglobin F&A2 Control Set
Primary DI 04560189283671
Brand Hemoglobin F&A2 Control Set
Company TOSOH CORPORATION
Model N/A
Published 2016-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name JPD Hemoglobin A2 Quantitation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JPD Hemoglobin A2 Quantitation Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04560189283671 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04560189283671 04560189283671 4560189283671
GMDN Terms# Term, Definition table Term Definition Haemoglobin F (HbF) IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 690571724 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04560189283114 TSKgel G7 β-Thal. HSi TOSOH CORPORATION JPD 2016-09-24 04560189283503 G7 Beta-Thalassemia Elution Buffer Kit TOSOH CORPORATION JPD 2016-09-24 04560189283664 Hemoglobin F&A2 Calibrator TOSOH CORPORATION JPD 2016-09-24 00847817000096 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817000447 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817000805 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003301 D-10 BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003448 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003455 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003462 D-10 BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817003509 D-10 Dual BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817008610 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817008634 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817009204 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817009914 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817010606 Whole Blood Primer BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817012273 VARIANT II / VARIANT II TURBO BIO-RAD LABORATORIES, INC. JPD 2016-09-12 00847817012303 VARIANT II B-thalassemia BIO-RAD LABORATORIES, INC. JPD 2016-09-12 M52553340 Sickle-Thal Quik Column Kit HELENA LABORATORIES CORPORATION JPD 2016-09-07 M52553410 Beta-Thal HbA2 Quik Column Kit HELENA LABORATORIES CORPORATION JPD 2016-09-07
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