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1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.
a. tTG, DGP, and Control paramagnetic particles, preserved.
b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.
c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724100
In Commercial Distribution
- 08430793040471 ()
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex
1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.
a. tTG, DGP, and Control paramagnetic particles, preserved.
b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.
c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.
d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724120
In Commercial Distribution
- 08430793040532 ()
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex
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 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
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution
- 00857167005030 ()
EA001012
- Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution
- 00857167005023 ()
KT022006
- Multiple-genus respiratory virus antigen IVD, kit, multiplex
The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
A21101
In Commercial Distribution
- 00845533000017 ()
A21101
- Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex