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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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Influenza B Virus Control Stock
DIAGNOSTIC HYBRIDS, INC.
20-4720010
In Commercial Distribution

  • 30014613338529 ()
20-4720010

  • Influenza B virus antigen IVD, control
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
27302
In Commercial Distribution

  • 23661562273021 ()
  • 13661562273024 ()
27302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17302
In Commercial Distribution

  • 23661562173024 ()
  • 13661562173027 ()
17302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual tube method.
DIAGAST
210521
In Commercial Distribution

  • 23661562105216 ()
  • 13661562105219 ()
210521

  • Anti-B red blood cell grouping IVD, antibody
Aptima® HBV Quant Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HBV, VL, US IVD
In Commercial Distribution

  • 15420045506763 ()
PRD-03869

  • Hepatitis B virus nucleic acid IVD, control
Alinity m HBV CTRL Kit
ABBOTT MOLECULAR INC.
08N47-085
In Commercial Distribution

  • 00884999047815 ()
08N47-085

  • Hepatitis B virus nucleic acid IVD, control
Abbott RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
2N40-80
In Commercial Distribution

  • 00884999003064 ()
2N40-80

  • Hepatitis B virus nucleic acid IVD, control
Reusable SpO2 Sensor/Philips/大号Soft finger cover/Adult/3.0M/087/Tracelogix Corporation
Unimed Medical Supplies, Inc.
TL122113A300B-CA652
In Commercial Distribution

  • 06945664810432 ()


  • Pulse oximeter probe, reusable
Disposable NIBP Cuff/Textile/Double tube/大Adult/with BP12-P connector/Sage Services GROUP
Unimed Medical Supplies, Inc.
DC720D-C12
In Commercial Distribution

  • 06945664854382 ()


  • Blood pressure cuff, single-use
Disposable NIBP Cuff/TPU/Single tube/大Adult/with BP12 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1620S-C12-05
In Commercial Distribution

  • 16945664853979 ()
  • 06945664853972 ()


  • Blood pressure cuff, single-use
Disposable NIBP Cuff/TPU/Double tube/大Adult/with BD08 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1620D-C0808-05
In Commercial Distribution

  • 16945664853023 ()
  • 06945664853026 ()


  • Blood pressure cuff, single-use
Disposable NIBP Cuff/Textile/Single tube/大Adult/with BP17 connector/No Unimed Logo
Unimed Medical Supplies, Inc.
N1720S-C17-05
In Commercial Distribution

  • 16945664852224 ()
  • 06945664852227 ()


  • Blood pressure cuff, single-use
Alinity s HBsAg Reagent Kit
Abbott Ireland Diagnostics
06P0260
In Commercial Distribution

  • 00380740136819 ()
06P0260

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity s HBsAg Confirmatory Reagent Kit
Abbott Ireland Diagnostics
06P0359
In Commercial Distribution

  • 00380740136789 ()
06P0359

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ABBOTT PRISM HBsAg Assay Kit
ABBOTT LABORATORIES
6D19-68
Not in Commercial Distribution

  • 00380740062989 ()
06D1968

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
ABBOTT PRISM HBsAg Confirmatory Assay Kit
ABBOTT LABORATORIES
6E51-68
Not in Commercial Distribution

  • 00380740062972 ()
06E5168

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741034162
In Commercial Distribution

  • 07613336183137 ()
08741034162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09014926162
In Commercial Distribution

  • 07613336228487 ()
  • 07613336183106 ()
09014926162

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814848162
In Commercial Distribution

  • 07613336228456 ()
  • 07613336183076 ()
08814848162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN S.P.A.
318250
In Commercial Distribution

  • 18056771500187 ()
  • 08056771500180 ()


  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
P001930
In Commercial Distribution

  • 08056771102353 ()


  • Hepatitis B virus e-antigen IVD, kit, enzyme immunoassay (EIA)
Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
Influenza B DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013200.V2-BULK
In Commercial Distribution

  • 30014613330400 ()
01-013200.V2-BULK

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
No Description
Microgenics Corporation
960041
Not in Commercial Distribution

  • 00884883006386 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, control
NCL-L-Akt-Phos is intended for the qualitative identification by light microscopy of Akt (Phosphorylated) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AKT-PHOS-L-CE
Not in Commercial Distribution

  • 05055331316875 ()
NCL-L-AKT-PHOS

  • Protein kinase B IVD, antibody
Alinity s HBsAg Calibrator Kit
Abbott Ireland Diagnostics
06P0204
In Commercial Distribution

  • 00380740136772 ()
06P0204

  • Hepatitis B virus surface antigen IVD, calibrator
Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator
No Description
DIASORIN SPA
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
N0143
In Commercial Distribution

  • E125N014308 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBV 1E6 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVH202
In Commercial Distribution

  • 00812242030697 ()
HBVH202

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVL201
In Commercial Distribution

  • 00812242030680 ()
HBVL201

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator
Aptima® HBV Quant Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HBV VL, US IVD
In Commercial Distribution

  • 15420045506756 ()
PRD-03872

  • Hepatitis B virus nucleic acid IVD, calibrator
Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator
Abbott RealTime HBV Calibrator Kit
ABBOTT MOLECULAR INC.
2N40-70
In Commercial Distribution

  • 00884999003057 ()
2N40-70

  • Hepatitis B virus nucleic acid IVD, calibrator
GBS Positive Run Control
EXACT DIAGNOSTICS, LLC
12020069
In Commercial Distribution

  • 03610522384389 ()
12020069

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control
VIROTROL IV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00111
In Commercial Distribution

  • 00847661002611 ()
00111

  • Hepatitis B virus e-antigen total antibody IVD, control
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