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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
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
For Sampling of Collected Blood and Blood Components. For Laboratory Testing Only. Sterile Fluid Path.
Fresenius Kabi AG
4R2335H
In Commercial Distribution
- 14086000101421 ()
- 04086000101424 ()
- 24086000101428 ()
4R2335H
- Blood transfer set
The PatientTouch Blood Product Administration is a software application that helps support nurse documentation of blood product administrations. Additionally, through the use of bar code technology, the solution will electronically acknowledge a match between the blood unit to be administered and the patient. The software It is limited to use in acute care hospitals by licensed, trained, and registered nursing professionals.
PATIENTSAFE SOLUTIONS, INC.
3.3.1
In Commercial Distribution
- 00853209005006 ()
PTA BPA
- Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2018
In Commercial Distribution
- 00853023006173 ()
- Blood bank information system application software
No Description
Cerner Corporation
Bridge2016
In Commercial Distribution
- 00853023006104 ()
- Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2012
In Commercial Distribution
- 00853023006098 ()
- Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion2015
In Commercial Distribution
- 00853023006067 ()
- Blood bank information system application software