Product Classification / EMDN Category
FDA Product Code: KSF
Directory of devices assigned to product classification code KSF.
gudid
ORTHO Daily QC Simulated Whole Blood Quality Control Kit
Manufacturer: MILLIPORE (U.K.) LIMITED
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gudid
PA APPLICATOR COTTON 6 NS WOOD 100/BG 10BG/BX 10BX/CS - (CS)
Manufacturer: NATIONAL DISTRIBUTION & CONTRACTING, INC.
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gudid
ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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gudid
ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 1 Multi-Marker Negative Control 12 x 3.5 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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gudid
ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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gudid
ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Manufacturer: Lgc Clinical Diagnostics, Inc.
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gudid
Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells.
Manufacturer: IMMUCOR, INC.
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gudid
Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has one (1) vial.
Manufacturer: IMMUCOR, INC.
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gudid
Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.
Manufacturer: IMMUCOR, INC.
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gudid
Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has three (3) vials.
Manufacturer: IMMUCOR, INC.
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gudid
corQC EXTEND Complete is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a five vial set.
Manufacturer: IMMUCOR, INC.
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gudid
corQC EXTEND Standard is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a single vial product.
Manufacturer: IMMUCOR, INC.
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gudid
Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials.
Manufacturer: IMMUCOR, INC.
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gudid
Complement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension of selected weak D red blood cells. This product is a one (1) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set.
Manufacturer: IMMUCOR, INC.
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gudid
corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
Manufacturer: IMMUCOR, INC.
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gudid
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
Manufacturer: IMMUCOR, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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VIROTROL II (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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VIROTROL HIV-2 (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL HIV-2 (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL HIV-2 (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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VIROTROL HIV-1 Ag (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL II (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL II (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL II (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL HIV-1 Ag (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL III (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL III (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
VIROTROL I (An unassayed (human) serological control.)
Manufacturer: BIO-RAD LABORATORIES, INC.
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gudid
IgG-coated red blood cells for the control of antiglobulin test; 10ml
Manufacturer: Bio-Rad Medical Diagnostics GmbH
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gudid
For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal)
Manufacturer: Bio-Rad Medical Diagnostics GmbH
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gudid
Set of 2 x 8 x5 mL pooled whole blood (15.0 2.0%) for quality control testing for use with the IH-System
Manufacturer: Bio-Rad Medical Diagnostics GmbH
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gudid
Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes
Manufacturer: Bio-Rad Medical Diagnostics GmbH
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gudid
Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml
Manufacturer: Bio-Rad Medical Diagnostics GmbH
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gudid
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
Manufacturer: American National Red Cross
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gudid
Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells.
Manufacturer: American National Red Cross
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gudid
MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques.
Manufacturer: HEMO BIOSCIENCE INC
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gudid
MQC is intended for the quality control of routine blood bank reagents when tested by tube technique.
Manufacturer: HEMO BIOSCIENCE INC
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gudid
C3 Control Cells are used to confirm the reactivity of anti-C3 in Anti-human globulin.
Manufacturer: HEMO BIOSCIENCE INC
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gudid
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
Manufacturer: HEMO BIOSCIENCE INC
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gudid
The Ortho Confidence Manual System is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU).
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
For control of the indirect and direct antiglobulin test. ALBAcyte C3 Coated Red Blood Cells is used as a control to confirm the presence or absence of Anti-C3 reactivity of Anti-Human Globulin Reagent and as indicator cells in AHG testing.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
AlbaQ-Chek is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques.
Manufacturer: ALBA BIOSCIENCE LIMITED
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gudid
Reagent Red Blood Cells (Pooled Cells) Ortho Coombs Control
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.
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gudid
Blood Grouping Reagent Control, formulated for Automated Systems, Beckman Coulter PK System
Manufacturer: DIAGAST
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