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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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Roche Diagnostics GmbH
08924163160
In Commercial Distribution

  • 07613336170182 ()
08924163160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007514
In Commercial Distribution

  • 10628451188268 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007521
In Commercial Distribution

  • 10628451188251 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007538
In Commercial Distribution

  • 10628451188244 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007569
In Commercial Distribution

  • 10628451188237 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal G4 Rapid HIV-1/2 Antibody Test (Reveal G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815311007552
In Commercial Distribution

  • 10628451188220 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
HIV-1/2 Antibody Test Controls (Test Controls) are external quality control agents intended for use only with Reveal G4. These Test Controls should be used in conjunction with Good Laboratory Practices in laboratories that have established an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met.
MedMira Laboratories Inc
815311007545
In Commercial Distribution

  • 10628451188213 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Reveal® G4 Rapid HIV-1/2 Antibody Test (Reveal® G4) is a single use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Human Immunodeficiency Virus Type 2 (HIV-2) in human whole blood (venipuncture and fingerstick), serum, and plasma. Reveal® G4 is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and/or HIV-2. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results. When multiple rapids tests are available, this test should be used in appropriate multi-test algorithms.
MedMira Laboratories Inc
815211007507
In Commercial Distribution

  • 10628451188169 ()


  • HIV1/HIV2 antibody IVD, kit, rapid ICT, clinical
Plasma/Fluid Transfer Set 100 mL Bag, 12 mL Syringe and Adapter Cap Assembly
CHARTER MEDICAL, LTD.
03-220-TMBC
In Commercial Distribution

  • 00817827021640 ()
  • 00817827021145 ()
03-220-TMBC

  • Blood transfer set
Plasma/Fluid Transfer Set with Tube Adapter
CHARTER MEDICAL, LTD.
03-220-BD
Not in Commercial Distribution

  • 00817827021626 ()
  • 00817827021121 ()
03-220-BD

  • Blood transfer set
Plasma/Fluid Transfer Set 20ml Syringe and Adapter Cap
CHARTER MEDICAL, LTD.
03-220-BC-20
In Commercial Distribution

  • 00817827021107 ()
  • 00817827021602 ()
03-220-BC-20

  • Blood transfer set
Plasma Transfer Set 2" Tubing with Male Luer Adapter
CHARTER MEDICAL, LTD.
03-220-94
In Commercial Distribution

  • 00817827021589 ()
  • 00817827021787 ()
  • 00817827021084 ()
03-220-94

  • Blood transfer set
Plasma Transfer Sets 2" tubing with Pinch Clamp and Female Luer Adapter
CHARTER MEDICAL, LTD.
03-220-92
In Commercial Distribution

  • 00817827021572 ()
  • 00817827021770 ()
  • 00817827021077 ()
03-220-92

  • Blood transfer set
Plasma Transfer Sets Duel syringe adapters, entry port and piercing pin
CHARTER MEDICAL, LTD.
03-220-50
In Commercial Distribution

  • 00817827021756 ()
  • 00817827021053 ()
  • 00817827021558 ()
03-220-50

  • Blood transfer set
Plasma/Fluid Transfer Set with Adapter Cap and Tubing Assembly
CHARTER MEDICAL, LTD.
03-220-100
In Commercial Distribution

  • 00817827021039 ()
  • 00817827021534 ()
03-220-100

  • Blood transfer set
Plasma/Fluid Transfer Set 24" Tubing with two piercing pins
CHARTER MEDICAL, LTD.
03-220-00
In Commercial Distribution

  • 00817827021725 ()
  • 00817827021022 ()
  • 00817827021923 ()
  • 00817827021527 ()
03-220-00

  • Blood transfer set
ART PRP 2-Step Processing Kit
Celling Biosciences
1651-0001
In Commercial Distribution

  • 00817771029983 ()
1651-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Device with SightWheel
Celling Biosciences
1601W-0001
In Commercial Distribution

  • 00817771029525 ()
1601W-0001

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174
Celling Biosciences
1601-0001
Not in Commercial Distribution

  • 00817771028887 ()
Duplicate See 000817771029174

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP PLus Processing Kit
Celling Biosciences
0885-1060
In Commercial Distribution

  • 00817771027552 ()
0885-1060

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Processing Kit
Celling Biosciences
0885-0060
In Commercial Distribution

  • 00817771027538 ()
0885-0060

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP Device
Celling Biosciences
0885-0001
In Commercial Distribution

  • 00817771027491 ()
0885-0001

  • Haematological concentrate system preparation kit, platelet concentration
120cc: Graft Delivery Kit
Celling Biosciences
0852-0120
In Commercial Distribution

  • 00817771027392 ()
0852-0120

  • Bone graft syringe, single-use
Graft Delivery Kit
Celling Biosciences
0852-0001
In Commercial Distribution

  • 00817771027385 ()
0852-0001

  • Bone graft syringe, single-use
Blood Draw Kit
Celling Biosciences
0851-3060
In Commercial Distribution

  • 00817771027378 ()
0851-3060

  • Bone graft syringe, single-use
Small Volume Bone Marrow Aspiration Kit
Celling Biosciences
0851-1070
In Commercial Distribution

  • 00817771027361 ()
0851-1070

  • Bone graft syringe, single-use
Bone Marrow Aspiration Kit
Celling Biosciences
0851-1060
In Commercial Distribution

  • 00817771027354 ()
0851-1060

  • Bone graft syringe, single-use
BMA Kit Standard
Celling Biosciences
0851-0061
In Commercial Distribution

  • 00817771027323 ()
0851-0061

  • Bone graft syringe, single-use
BMA Kit with 30cc Syringes
Celling Biosciences
0851-0030
In Commercial Distribution

  • 00817771027316 ()
0851-0030

  • Bone graft syringe, single-use
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution

  • 00817955020010 ()


  • Blood bank information system application software
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