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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Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-91
In Commercial Distribution

  • 00884999038462 ()
2N40-91

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution

  • 00884999037762 ()
2N43-03

  • Laboratory instrument/analyser application software IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Tubigrip B Natural 0.5m 7x12pcs
Mölnlycke Health Care AB
1510
In Commercial Distribution

  • 07332551943400 ()
  • 05055158005297 ()
  • 05055158005280 ()

  • B


  • Tubular support bandage, Hevea-latex
Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422854
In Commercial Distribution

  • 05019279403899 ()

  • B
32-422854

  • Surgical implant template, reusable
Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution

  • 05019279403882 ()

  • B
32-422853

  • Surgical implant template, reusable
Tubigrip B Beige x 10m
Mölnlycke Health Care AB
1449
In Commercial Distribution

  • 07332551449780 ()
  • 07332551449797 ()
  • 07332551948184 ()

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Natural x 10m
Mölnlycke Health Care AB
1436
In Commercial Distribution

  • 07332551449421 ()
  • 07332551449438 ()
  • 07332551947903 ()

  • B


  • Tubular support bandage, Hevea-latex
Tubigrip B Nat 1m 5x12pcs
Mölnlycke Health Care AB
1520
In Commercial Distribution

  • 07332551945879 ()
  • 07332551448684 ()
  • 07332551448707 ()

  • B


  • Tubular support bandage, Hevea-latex
Toxi-Titer Diluent, 50 mL
MARDX DIAGNOSTICS, INC.
B1029-70B
In Commercial Distribution

  • 05391516748841 ()
B1029-70B

  • Clostridium difficile antigen IVD, reagent
Clostridium difficile Antitoxin, 3 mL
MARDX DIAGNOSTICS, INC.
B1029-70C
In Commercial Distribution

  • 05391516748858 ()
B1029-70C

  • Clostridium difficile antigen IVD, reagent
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Positive Calibrator Kit
In Commercial Distribution

  • 00859882007696 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Negative Calibrator Kit
In Commercial Distribution

  • 00859882007689 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 1
In Commercial Distribution

  • 00859882007672 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 1
In Commercial Distribution

  • 00859882007665 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Discriminatory Probe Kit
In Commercial Distribution

  • 00859882007603 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
High Volume Calibrator Kit
In Commercial Distribution

  • 00859882007597 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 4
In Commercial Distribution

  • 00859882007580 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 3
In Commercial Distribution

  • 00859882007573 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
5K Kit Box 2
In Commercial Distribution

  • 00859882007566 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 4
In Commercial Distribution

  • 00859882007542 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 2
In Commercial Distribution

  • 00859882007528 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Low Volume Calibrator Kit
In Commercial Distribution

  • 00859882007559 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Procleix Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) RNA, hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA in plasma and serum specimens from human donors.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
1K Kit Box 3
In Commercial Distribution

  • 00859882007535 ()


  • HIV1/HIV2/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002345
In Commercial Distribution

  • 10888234000273 ()
0002345

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
This configuration of the product contains four (4) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
IMMUCOR, INC.
0002338
In Commercial Distribution

  • 10888234000259 ()
0002338

  • Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
2-3% Reagent Red Blood Cells for ABO Reverse Grouping, ALBAcyte Orr Cells, for tube techniques.
ALBA BIOSCIENCE LIMITED
Z421U
In Commercial Distribution

  • 05060242471155 ()


  • Group O Rh (D) negative reagent red blood cell IVD, antigen
BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes
Becton, Dickinson And Company
662995
In Commercial Distribution

  • 00382906629951 ()
662995

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Multitest IMK Kit 50 Tests US-IVD
Becton, Dickinson And Company
662965
In Commercial Distribution

  • 00382906629654 ()
662965

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Multitest™ 6-color TBNK
Becton, Dickinson And Company
662967
In Commercial Distribution

  • 00382906629678 ()
662967

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Multitest™ 6-Color TBNK
BECTON, DICKINSON AND COMPANY
644611
Not in Commercial Distribution

  • 00382906446114 ()
644611

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD® CD3 (SK7) FITC
Becton, Dickinson And Company
349201
In Commercial Distribution

  • 00382903492015 ()
349201

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD® CD3 (SK7) FITC
Becton, Dickinson And Company
340542
In Commercial Distribution

  • 00382903405428 ()
340542

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Multitest™ IMK Kit
BECTON, DICKINSON AND COMPANY
340503
Not in Commercial Distribution

  • 00382903405039 ()
340503

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Multitest CD3/CD8/CD45/CD4 50 Tests IVD
Becton, Dickinson And Company
340499
In Commercial Distribution

  • 00382903404995 ()
340499

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Tritest CD3 FITC/CD19 PE/CD45 PerCP IVD
Becton, Dickinson And Company
340381
In Commercial Distribution

  • 00382903403813 ()
340381

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD FACSCount Control Kit 25 Tests IVD
Becton, Dickinson And Company
340166
In Commercial Distribution

  • 00382903401666 ()
340166

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ CD3/Anti-HLA-DR
Becton, Dickinson And Company
340048
In Commercial Distribution

  • 00382903400485 ()
340048

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD® CD8 (SK1) PE
Becton, Dickinson And Company
340046
In Commercial Distribution

  • 00382903400461 ()
340046

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ CD3/CD8
Becton, Dickinson And Company
340044
In Commercial Distribution

  • 00382903400447 ()
340044

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD® Simultest CD3/CD4
Becton, Dickinson And Company
340043
In Commercial Distribution

  • 00382903400430 ()
340043

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ CD3/CD16+CD56
Becton, Dickinson And Company
340042
In Commercial Distribution

  • 00382903400423 ()
340042

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ Leucogate™ CD45/CD14
Becton, Dickinson And Company
340040
In Commercial Distribution

  • 00382903400409 ()
340040

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ CD4/CD8
Becton, Dickinson And Company
340039
In Commercial Distribution

  • 00382903400393 ()
340039

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD FACSCount CD4 Reagent Kit 50 Tests
Becton, Dickinson And Company
339010
In Commercial Distribution

  • 00382903390106 ()
339010

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Multitest 6-Color TBNK Kit W/Trucount
BECTON, DICKINSON AND COMPANY
337166
Not in Commercial Distribution

  • 00382903371662 ()
337166

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ IMK Plus
Becton, Dickinson And Company
349217
In Commercial Distribution

  • 00382903492176 ()
349217

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Simultest™ CD3/CD19
Becton, Dickinson And Company
349211
In Commercial Distribution

  • 00382903492114 ()
349211

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
BD Leucocount Combo RBC/PLT Control Kit
BECTON, DICKINSON AND COMPANY
341003
Not in Commercial Distribution

  • 00382903410033 ()
341003

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Leucocount PLT Control Kit 25 Tests IVD
BECTON, DICKINSON AND COMPANY
341002
Not in Commercial Distribution

  • 00382903410026 ()
341002

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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