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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution

  • 08887581000016 ()
07110888036

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution

  • 08887581000009 ()
0711088018

  • Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
Blood Glucose Test Strips - 50 Test Strips (per bottle) - sold in a carton of 2 bottles (100 test strips total).
ASCENSIA DIABETES CARE US INC.
7312
In Commercial Distribution

  • 40301939737219 ()
  • 00301937312212 ()
  • 10301937312219 ()
  • 40301937312210 ()
  • 0193-7312-21 ()
  • 00301937312014 ()
  • 40301935541049 ()
  • 40301939770513 ()
83624788

  • Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
ASCENSIA DIABETES CARE US INC.
7278
In Commercial Distribution

  • 40301937278707 ()
  • 00301937278709 ()
  • 10301937278706 ()
  • 00301937278013 ()
85701231

  • Glucose monitoring system IVD, home-use
The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products.
Baxter Healthcare Corporation
ADS201807
In Commercial Distribution

  • 25413765583524 ()
  • 05413765583520 ()
  • 75413765583529 ()
ADS201807

  • Open-surgery adhesive/sealant applicator, dual-channel
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
SDM-SYS-9000-3D
In Commercial Distribution

  • 15420045510784 ()
SDM-SYS-9000-3D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
SDM-SYS-9000-2D
In Commercial Distribution

  • 15420045510777 ()
SDM-SYS-9000-2D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
SDM-SYS-6000-3D
In Commercial Distribution

  • 15420045510760 ()
SDM-SYS-6000-3D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
SDM-SYS-6000-2D
In Commercial Distribution

  • 15420045510753 ()
SDM-SYS-6000-2D

  • Stationary mammographic x-ray system, digital
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.
Hologic, Inc.
SDA-SYS-3000-2D
In Commercial Distribution

  • 15420045510616 ()
SDA-SYS-3000-2D

  • Stationary mammographic x-ray system, digital
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