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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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COM PLACM INSDE #20 TIN REG
NORDENT MANUFACTURING INC
PFI20T
In Commercial Distribution

  • 00840018635821 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #6
NORDENT MANUFACTURING INC
PFIF6
In Commercial Distribution

  • 00840018635098 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #5
NORDENT MANUFACTURING INC
PFIF5
In Commercial Distribution

  • 00840018635081 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #4
NORDENT MANUFACTURING INC
PFIF4
In Commercial Distribution

  • 00840018635074 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #3
NORDENT MANUFACTURING INC
PFIF3
In Commercial Distribution

  • 00840018635067 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #2
NORDENT MANUFACTURING INC
PFIF2
In Commercial Distribution

  • 00840018635050 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INST DE FELTS #1
NORDENT MANUFACTURING INC
PFIF1
In Commercial Distribution

  • 00840018635043 ()


  • Margin finishing dental file/rasp, reusable
RECL OB II ARM CAP COM
GF HEALTH PRODUCTS, INC.
IN597GCOM
In Commercial Distribution

  • M368IN597GCOM1 ()


  • Reclining chair
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
BcM Anti-HBc IgM Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488616
In Commercial Distribution

  • 00630414977737 ()
L2KMC2(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820524160
Not in Commercial Distribution

  • 04015630919420 ()
11820524160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876333160
Not in Commercial Distribution

  • 04015630911622 ()
11876333160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
No Description
Roche Diagnostics GmbH
11820532160
In Commercial Distribution

  • 04015630911073 ()
11820532160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820567160
Not in Commercial Distribution

  • 04015630911615 ()
11820567160

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876309160
Not in Commercial Distribution

  • 04015630911059 ()
11876309160

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
11876317160
Not in Commercial Distribution

  • 04015630910908 ()
11876317160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 04015630999286 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
No Description
Roche Diagnostics GmbH
07251076190
Not in Commercial Distribution

  • 04015630940028 ()
07251076190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
07027427190
In Commercial Distribution

  • 04015630939862 ()
07027427190

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Anti-HBe PC Elecsys
Roche Diagnostics GmbH
11876384160
In Commercial Distribution

  • 04015630938872 ()
11876384160

  • Hepatitis E virus total antibody IVD, control
No Description
Roche Diagnostics GmbH
11820613160
In Commercial Distribution

  • 04015630938865 ()
11820613160

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11876376160
Not in Commercial Distribution

  • 04015630934843 ()
11876376160

  • Hepatitis B virus e-antigen IVD, control
No Description
Roche Diagnostics GmbH
04687787160
Not in Commercial Distribution

  • 04015630939008 ()
04687787160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820583160
Not in Commercial Distribution

  • 04015630935215 ()
11820583160

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
04927931160
Not in Commercial Distribution

  • 04015630923045 ()
04927931160

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
04927826160
Not in Commercial Distribution

  • 04015630923038 ()
04927826160

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801425
In Commercial Distribution

  • 10758750002795 ()
6801425

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802451
In Commercial Distribution

  • 10758750002771 ()
6802451

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802450
In Commercial Distribution

  • 10758750002764 ()
6802450

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBs Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801926
In Commercial Distribution

  • 10758750001699 ()
  • 20758750001696 ()
6801926

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801925
In Commercial Distribution

  • 10758750001682 ()
  • 20758750001689 ()
6801925

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBeAg Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801820
In Commercial Distribution

  • 10758750001453 ()
  • 20758750001450 ()
6801820

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products HBeAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801819
In Commercial Distribution

  • 10758750001446 ()
  • 20758750001443 ()
6801819

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBe Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801817
In Commercial Distribution

  • 10758750001439 ()
  • 20758750001436 ()
6801817

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801816
In Commercial Distribution

  • 10758750001422 ()
  • 20758750001429 ()
6801816

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
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