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Found 10 results
510(k) Data Aggregation
K Number
K192842Device Name
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
Manufacturer
Eurotrol B.V.
Date Cleared
2019-11-15
(43 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
Device Description
HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available.
HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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K Number
K182744Device Name
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
Manufacturer
EUROTROL B.V.
Date Cleared
2019-02-01
(126 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.
Device Description
HemoTrol® WB is an assayed hemoglobin quality control material intended for professional use in the verification of the precision and accuracy of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® WB contains bovine red blood cells with hemoglobin lysates in MetHb and additional stabilizers. For daily quality control, three physiological relevant levels are available.
HemoTrol® WB solutions are filled in reclosable plastic primary containers. Each bottle contains 1.1 g of HemoTrol® WB solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
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K Number
K070546Device Name
LYPHOCHEK DIABETES CONTROL
Manufacturer
Bio-Rad Laboratories
Date Cleared
2007-04-02
(35 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lyphochek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Device Description
This is a lyophilized product prepared from human whole blood containing preservatives and stabilizers.
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K Number
K070334Device Name
R&D SICKLE QC CONTROL
Manufacturer
R & D SYSTEMS, INC.
Date Cleared
2007-03-29
(52 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
Device Description
Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits. The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
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K Number
K052838Device Name
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
Manufacturer
BIO-RAD
Date Cleared
2005-11-09
(33 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Device Description
This is a liquid product prepared from human whole blood containing preservatives and stabilizers.
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K Number
K032791Device Name
GLYCOHEMOSURE HBA1C CONTROL
Manufacturer
QUANTIMETRIX CORP.
Date Cleared
2003-10-30
(52 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.
Device Description
The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.
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K Number
K003030Device Name
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
Manufacturer
BIO-RAD
Date Cleared
2000-11-29
(62 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993321Device Name
R&D HGB/GLC WHOLE BLOOD CONTROL
Manufacturer
R & D SYSTEMS, INC.
Date Cleared
1999-11-12
(39 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.
R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
Device Description
The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.
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K Number
K964052Device Name
HEMOCUE HEMOTROL
Manufacturer
DIRECT SOLUTIONS
Date Cleared
1996-11-06
(37 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemoCue HemoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are included for comparison.
Device Description
These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.
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K Number
K963908Device Name
HEMOCUE HEMOLIN
Manufacturer
DIRECT SOLUTIONS
Date Cleared
1996-10-16
(16 days)
Product Code
GGM
Regulation Number
864.8625Why did this record match?
Product Code :
GGM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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