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The PakPlus assay is a qualitative solid-phase enzyme-linked immunosorbent assay (ELISA) designed to screen for antibodies to HLA Class I and platelet glycoprotein (GP) IV antigens, and to polymorphic epitopes on the platelet glycoproteins IIb/IIIa, Ib/IX, and Ia/II.
IMMUCOR GTI DIAGNOSTICS, INC.
PAKPLUS100
Not in Commercial Distribution
- 10888234500674 ()
PAKPLUS100
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution
- 10888234500667 ()
EGEL48
- Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution
- 10888234500650 ()
403594
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution
- 10888234500643 ()
404601
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution
- 10888234500636 ()
404600
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404598
Not in Commercial Distribution
- 10888234500629 ()
404598
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404590
Not in Commercial Distribution
- 10888234500599 ()
404590
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12 and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404589
Not in Commercial Distribution
- 10888234500582 ()
404589
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution
- 10888234500575 ()
404588
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404579
Not in Commercial Distribution
- 10888234500568 ()
404579
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution
- 10888234500551 ()
404578
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution
- 10888234500544 ()
404577
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution
- 10888234500537 ()
404576
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
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.
IMMUCOR, INC.
0420410
In Commercial Distribution
- 10888234001751 ()
0420410
- Multiple immunohaematology test IVD, control
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.
IMMUCOR, INC.
0420403
In Commercial Distribution
- 10888234001744 ()
0420403
- Multiple immunohaematology test IVD, control
Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capture-P and Capture-P Ready-Screen Solid Phase assays.
IMMUCOR, INC.
0066905
In Commercial Distribution
- 10888234001577 ()
0066905
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in solid phase assays for the detection of IgG red blood cell antibodies to corresponding red blood cell antigens (e.g., antibody screening, selected red blood cell panels, crossmatching, or antigen phenotyping).
IMMUCOR, INC.
0066903
In Commercial Distribution
- 10888234001553 ()
0066903
- Solid-phase red blood cell adherence antibody/antigen IVD
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.
IMMUCOR, INC.
0066297
In Commercial Distribution
- 10888234001331 ()
0066297
- Multiple immunohaematology test IVD, control
DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the four (4) vial configuration.
IMMUCOR, INC.
0066125
In Commercial Distribution
- 10888234001119 ()
0066125
- Multiple immunohaematology test IVD, control
WB corQC is incorporated as a set of run controls with blood sample testing for the daily quality control of blood bank reagents on automated instruments. A set of WB corQC is composed of four tubes of varying antigenic and antibody makeup. Each packaging of the WB corQC product contains a pair of each of the four tubes.
IMMUCOR, INC.
0066090
In Commercial Distribution
- 10888234001096 ()
0066090
- Multiple immunohaematology test IVD, control
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.
IMMUCOR, INC.
0066089
In Commercial Distribution
- 10888234001089 ()
0066089
- Multiple immunohaematology test IVD, control
Specimen Diluent is a ready for use isotonic solution used for diluting red blood cells from blood samples for testing on Immucor automated instruments. This product configuration is ten (10) vials of 11.5 mL volume.
IMMUCOR, INC.
0066052
In Commercial Distribution
- 10888234001065 ()
0066052
- Cell preservation/storage/dilution solution IVD
Anti-A1 Lectin (Dolichos biflorus) Blood Grouping Lectin is used to differentiate A1 red blood cells from those of other A subgroups in saline slide or tube tests. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0012280
In Commercial Distribution
- 10888234000952 ()
0012280
- Anti-A1 red blood cell grouping IVD, lectin
The FMH RapidScreen kit is intended for use in the detection of D-positive red blood cells in D-negative mothers.
IMMUCOR, INC.
0007893
In Commercial Distribution
- 10888234000907 ()
0007893
- Foeto-maternal haemorrhage/Kleihauer test IVD, reagent
Gamma EGA Kit is intended for use in dissociation of IgG from red blood cells so that the treated red blood cells can be further antigen typed or used for serological testing.
IMMUCOR, INC.
0007865
In Commercial Distribution
- 10888234000877 ()
0007865
- Red cell antibody eluting IVD, kit
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007058
In Commercial Distribution
- 10888234000716 ()
0007058
- Bromelin immunohaematology reagent IVD
GammaZyme-F is used in two-stage (pretreatment of red blood cells) enzyme test systems for blood group antibody detection. GammaZyme-F is a stabilized solution of ficin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007056
In Commercial Distribution
- 10888234000709 ()
0007056
- Ficin immunohaematology reagent IVD
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.
IMMUCOR, INC.
0006428
In Commercial Distribution
- 10888234000600 ()
0006428
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Capture LISS is for use as a low ionic strength potentiator and sample addition indicator in Capture solid phase tests for the detection of antibodies. This product is the 11.5 mL vial version with ten vials packaged.
IMMUCOR, INC.
0006420
In Commercial Distribution
- 10888234000587 ()
0006420
- Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Platelet Wash and Storage Solution (PWSS) is used to wash, suspend and store platelets. The solution is provided in a 1 liter bag.
IMMUCOR, INC.
0005035
In Commercial Distribution
- 10888234000488 ()
0005035
- Platelet storage solution
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.
IMMUCOR, INC.
0002417
In Commercial Distribution
- 10888234000341 ()
0002417
- Multiple immunohaematology test IVD, control
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.
IMMUCOR, INC.
0002227
In Commercial Distribution
- 10888234000211 ()
0002227
- Multiple immunohaematology test IVD, control
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.
IMMUCOR, INC.
0002225
In Commercial Distribution
- 10888234000198 ()
0002225
- Multiple immunohaematology test IVD, control
The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution
- 00607158000007 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The DPP® HIV-Syphilis is a single-use rapid, qualitative, multiplex, immunoassay for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2), and/or Treponema pallidum bacteria (the causative agent of syphilis) in fingerstick whole blood, potassium-EDTA venous whole blood or potassium-EDTA plasma specimens. The test is intended to be used with the DPP Micro Reader. The test is intended for use by trained professionals in point of care and laboratory settings to aid in the diagnosis of HIV and syphilis infection.
Chembio Diagnostic Systems Inc.
65-9502-0
In Commercial Distribution
- 00607158000083 ()
- HIV1/HIV2/Treponema pallidum antibody IVD, kit, rapid ICT, clinical
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio HIV 1/2 STAT-PAK® Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9549-0
In Commercial Distribution
- 00607158000076 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma specimens. The Chembio HIV 1/2 STAT-PAK® assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of HIV Running Buffer, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9505-1
In Commercial Distribution
- 00607158000052 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Chembio HIV Reactive/Nonreactive Controls are quality control reagents for use with the Chembio DPP HIV 1/2 Assay only. Chembio HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control) as described.
One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.5mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.5mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9552-0
In Commercial Distribution
- 00607158000045 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® HIV Reactive/Nonreactive Controls are quality control reagents for use with the Clearview® COMPLETE HIV 1/2 Assay only. Clearview® HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user’s ability to properly perform the test and interpret the results. Each HIV Rapid Test Control Pack contains a Product Insert and three Vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control and one Nonreactive Control).
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-1, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of heat inactivated human plasma positive for antibodies to HIV-2, diluted in normal human plasma. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
One Vial containing 0.25 mL of normal human plasma negative for antibodies to HIV-1 and HIV-2. Negative for Hepatitis B surface antigen, Hepatitis C antibody and HTLV I/II antibodies.
Chembio Diagnostic Systems Inc.
60-9546-0
In Commercial Distribution
- 00607158000038 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution
- 00607158000021 ()
- HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test