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510(k) Data Aggregation
K Number
K083926Device Name
CD4 COUNT
Manufacturer
Streck
Date Cleared
2009-02-11
(42 days)
Product Code
GGL
Regulation Number
864.8625Why did this record match?
Product Code :
GGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument.
Device Description
CD4 Count is a suspension of stabilized human blood packaged in a plastic vial OD4 Obant 16 a cuppinelon the vials are packaged in a vacuum formed "clam-shell" box.
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K Number
K051633Device Name
CD-CHEX PLUS BC
Manufacturer
Streck
Date Cleared
2005-08-16
(57 days)
Product Code
GGL
Regulation Number
864.8625Why did this record match?
Product Code :
GGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CD-Chex Plus BC is designed to serve as a quality control specimen for clinical flow-cytometric procedures performed with Beckman Coulter® flow cytometry instruments.
Device Description
CD-Chex Plus BC is a suspension of stabilized human red blood cells and human white blood cells packaged in a plastic vial containing 3.0 mL volumes. The vials are packaged in a vacuum formed "clam-shell" box.
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K Number
K993126Device Name
CD-CHEX CD 34
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
1999-11-26
(67 days)
Product Code
GGL
Regulation Number
864.8625Why did this record match?
Product Code :
GGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CD Chex CD 34 is designed as a control sample for evaluating the binding of monoclonal antibody using flow cytometry. It is intended to be used with Becton Dickinson ProCount Progenitor Cell enumeration kit and with systems using ISHAGE protocol for CD 34 stem cell marker.
A clinical laboratory performing quantitative stem cell analysis needs a control specimen for verifying the measurement process. CD Chex CD 34 is such a specimen. It consists of stabilized placental blood containing a population of CD 34 positive stem cells. It is used as a procedural control for monitoring monoclonal antibody binding in flow cytometry methods. Users of Becton Dickinson ProCount Progenitor Cell Enumeration Kit or ISHAGE protocol can validate their CD 34 results by controlling the procedure with CD Chex CD 34.
Device Description
CD Chex CD 34 is a stabilized suspension of human placental blood containing red blood cells and white blood cells. It is packaged in glass vials containing 1 ml of product. Closures are polyproplylene screw caps. The package contains two vials of a single concentration and an assay sheet stating the expected values.
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K Number
K960894Device Name
CD-CHEX + RBC
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
1996-05-24
(80 days)
Product Code
GGL
Regulation Number
864.8625Why did this record match?
Product Code :
GGL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems
Device Description
CD-Chex PLUS is a suspension of stablized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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