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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00880304400092 800-0510 800-0510 JQC CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 1 Plasmax® Counterbalance
2 00880304999626 800-0544 800-0544 FMF Syringe, piston 2 PERFUSE STRIKE CAP
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9 00880304999619 800-0543 800-0543 FMF Syringe, piston 2 PERFUSE
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13 00880304681507 800-1004A 800-1004A KSS SUPPLIES, BLOOD-BANK 1 GPS® III Platelet Concentration System
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15 00880304681446 800-0517 800-0517 KSS SUPPLIES, BLOOD-BANK 1 Plasmax® Plus Plasma Concentration Kit
16 00880304484757 800-0270 800-0270 FMF Syringe, piston 2 Biomet®
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18 00880304680333 800-0546 800-0546 FMF Syringe, piston 2 PERFUSE DECOMPRESSION INSTRUMENTATION
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29 00880304460645 800-0744 800-0744 KSS SUPPLIES, BLOOD-BANK 1 GPS® III
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00880304681514 800-1007A 800-1007A GPS® III PLATELET CONCENTRATION SYSTEM BIOMET BIOLOGICS, LLC
2 00880304681507 800-1004A 800-1004A GPS® III Platelet Concentration System BIOMET BIOLOGICS, LLC
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40 19555240400137 A100100 A100100 DonorCare Needle Guard is intended to aid in the prevention of accidental needle DonorCare Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures. DonorCare® Needle Guard Small Channel ITL ASIA PACIFIC SDN. BHD.
41 14086000903209 4C2405 4C2405 Sampling Site Coupler Sampling Site Coupler FRESENIUS KABI AG
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43 10888234002314 0066906 0066906 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Captur Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the detection of IgG antibodies to platelets. Capture-P Indicator Red Cells are a suspension of red blood cells coated with rabbit anti-human IgG. The red blood cells are suspended in a buffered preservative solution to which chloramphenicol (0.25 mg/mL) , neomycin sulfate (0.1 mg/mL) and gentamycin sulfate (0.05 mg/mL) have been added as preservatives. Capture-P Indicator Red Cells IMMUCOR, INC.
44 10888234002291 0066908 0066908 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%). The reagent will turn from blue purple to sky blue or turquoise in the presence of normal human serum or plasma. Capture LISS IMMUCOR, INC.
45 10888234002147 0006418 0006418 Capture LISS is for use as a low ionic strength potentiator and sample addition 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 single 57 mL bottle version. Capture LISS IMMUCOR, INC.
46 10888234001577 0066905 0066905 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative 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. Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum IMMUCOR, INC.
47 10888234001560 0066904 0066904 Capture-P Solid Phase System is intended for use in the detection of antibodies Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is designed to detect the unexpected antiplatelet antibodies (antibody screening test) in a patient or donor population. Capture-P IMMUCOR, INC.
48 10888234001546 0066902 0066902 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-R Solid Phase Assays, including Capture-R Select, Capture-R Ready-Screen and Capture-R Ready-ID. Capture-R Positive Control Serum (Weak) contains antibodies to red blood cells and sodium azide added as a preservative. Capture-R Negative Control Serum contains no antibodies to red blood cells; sodium azide is added as a preservative. Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum IMMUCOR, INC.
49 10888234001300 0066251 0066251 Capture-P solid phase system is intended for use in the detection of antibodies Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product. Capture-P IMMUCOR, INC.
50 10888234001294 0066248 0066248 The Capture-P Control set is composed of both negative and weak positive control The Capture-P Control set is composed of both negative and weak positive control material to control both the Capture-P and Capture-P Ready-Screen tests. Capture-P Control set IMMUCOR, INC.