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 PLACEM INSTDE, #28 TIN, DL
NORDENT MANUFACTURING INC
REPFI28T
In Commercial Distribution

  • 00840018636439 ()


  • Margin finishing dental file/rasp, reusable
COM PLACEM INSTDE, #40 TIN, ST
NORDENT MANUFACTURING INC
PFI40T
In Commercial Distribution

  • 00840018635951 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INSDE #21 TIN REG
NORDENT MANUFACTURING INC
PFI21T
In Commercial Distribution

  • 00840018635838 ()


  • Margin finishing dental file/rasp, reusable
COM PLACM INSDE #20 TIN REG
NORDENT MANUFACTURING INC
PFI20T
In Commercial Distribution

  • 00840018635821 ()


  • Margin finishing dental file/rasp, reusable
Bone curettes MOLT 2/4 COM
A. Schweickhardt GmbH & Co. KG
1407-124
In Commercial Distribution

  • E89614071240 ()
1407-124

  • Periosteal elevator, reusable
Walton Com Extr,w/o lancet"
MARINA MEDICAL INSTRUMENTS, INC.
190-157C
In Commercial Distribution

  • 00840306822070 ()
190-157C

  • Comedo expressor
RECL OB II ARM CAP COM
GF HEALTH PRODUCTS, INC.
IN597GCOM
In Commercial Distribution

  • M368IN597GCOM1 ()


  • Reclining chair
K0434 PASCAL MAGNE COM/CER FIN
Peter Brasseler Holdings, LLC
5031007U0
In Commercial Distribution

  • 00887919971399 ()


  • Dental abrasive point, reusable
Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26203
In Commercial Distribution

  • 00847865013178 ()

  • Total Volume: 1.5 Milliliter
26203

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL
Bio-RAD Laboratories, Inc.
26202
In Commercial Distribution

  • 00847865013161 ()

  • Total Volume: 7.5 Milliliter
26202

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc IgM EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26201
In Commercial Distribution

  • 00847865013154 ()

  • Total Volume: 0.8 Milliliter
26201

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Positive Control,1.6 mL
Bio-RAD Laboratories, Inc.
26200
In Commercial Distribution

  • 00847865013147 ()

  • Total Volume: 1.6 Milliliter
26200

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Anti-HBc IgM EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26199
In Commercial Distribution

  • 00847865013130 ()

  • Total Volume: 30 Milliliter
26199

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc IgM EIA Conjugate Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26198
In Commercial Distribution

  • 00847865013123 ()

  • Total Volume: 30 Milliliter
26198

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent
Anti-HBc EIA, Negative Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26197
In Commercial Distribution

  • 00847865013116 ()

  • Total Volume: 0.8 Milliliter
26197

  • Hepatitis B virus core antigen IVD, control
Anti-HBc EIA, Specimen Diluent, 30 mL
Bio-RAD Laboratories, Inc.
26196
In Commercial Distribution

  • 00847865013109 ()

  • Total Volume: 30 Milliliter
26196

  • Hepatitis B virus core antigen IVD, reagent
Anti-HBc EIA, Cutoff Calibrator, 1.5 mL
Bio-RAD Laboratories, Inc.
26195
In Commercial Distribution

  • 00847865013093 ()

  • Total Volume: 1.5 Milliliter
26195

  • Hepatitis B virus core total antibody IVD, calibrator
Anti-HBc EIA, Positive Control, 0.8 mL
Bio-RAD Laboratories, Inc.
26194
In Commercial Distribution

  • 00847865013086 ()

  • Total Volume: 0.8 Milliliter
26194

  • Hepatitis B virus core antigen IVD, control
Anti-HBc EIA, Conjugate Reagent 30 mL
Bio-RAD Laboratories, Inc.
26193
In Commercial Distribution

  • 00847865013079 ()

  • Total Volume: 30 Milliliter
26193

  • Hepatitis B virus core antigen IVD, reagent
MONOLISA™ Anti-HBc EIA 192 Tests
Bio-RAD Laboratories, Inc.
26186
In Commercial Distribution

  • 00847865011372 ()

  • 192 tests
26186

  • Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA)
MONOLISA™ Anti-HBc IgM EIA, 192 Tests
Bio-RAD Laboratories, Inc.
26174
In Commercial Distribution

  • 00847865011365 ()

  • 192 tests
26174

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Anti-HBs EIA, Specimen Diluent 10 mL
Bio-RAD Laboratories, Inc.
26156
In Commercial Distribution

  • 00847865002110 ()

  • Total Volume: 10 Milliliter
26156

  • Hepatitis B virus surface total antibody IVD, reagent
Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL
Bio-RAD Laboratories, Inc.
26154
In Commercial Distribution

  • 00847865002097 ()

  • Total Volume: 1.8 Milliliter
26154

  • Hepatitis B virus surface total antibody IVD, calibrator
Anti-HBs EIA, Negative Control 1.5 mL
Bio-RAD Laboratories, Inc.
26153
In Commercial Distribution

  • 00847865002080 ()

  • Total Volume: 1.5 Milliliter
26153

  • Hepatitis B virus surface total antibody IVD, reagent
Anti-HBs EIA, Positive Control 1.5 mL
Bio-RAD Laboratories, Inc.
26152
In Commercial Distribution

  • 00847865002073 ()

  • Total Volume: 1.5 Milliliter
26152

  • Hepatitis B virus surface total antibody IVD, reagent
Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate
Bio-RAD Laboratories, Inc.
26151
In Commercial Distribution

  • 00847865002066 ()

  • Total Volume: 3 Milliliter
26151

  • Hepatitis B virus surface total antibody IVD, reagent
MONOLISA™ Anti-HBs EIA 192 tests
Bio-RAD Laboratories, Inc.
25220
In Commercial Distribution

  • 00847865002059 ()

  • 192 Tests
25220

  • Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)
MONOLISA™ Anti-HBs EIA Calibrator Kit
Bio-RAD Laboratories, Inc.
25219
In Commercial Distribution

  • 00847865002042 ()

  • 20 Tests
25219

  • Hepatitis B virus surface total antibody IVD, calibrator
Antibody to Hepatitis B Surface Antigen (Human) GS HBsAg 3.0 - HBsAg Confirmatory Assay 3.0
Bio-RAD Laboratories, Inc.
32594
In Commercial Distribution

  • 00847865001922 ()

  • 25 Tests
32594

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBsAg EIA 3.0 Low Positive Control, 8 mL
Bio-RAD Laboratories, Inc.
25110
In Commercial Distribution

  • 00847865001892 ()

  • Total Volume: 8 Milliliter
25110

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBsAg EIA 3.0 Positive Control, 8 mL
Bio-RAD Laboratories, Inc.
25109
In Commercial Distribution

  • 00847865001885 ()

  • Total Volume: 8 Milliliter
25109

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBsAg EIA 3.0 Negative Control, 12 mL
Bio-RAD Laboratories, Inc.
25108
In Commercial Distribution

  • 00847865001878 ()

  • Total Volume: 12 Milliliter
25108

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBsAg EIA 3.0 Conjugate Concentrate, 1.2 mL
Bio-RAD Laboratories, Inc.
25103
In Commercial Distribution

  • 00847865001854 ()

  • Total Volume: 1.2 Milliliter
25103

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 4800 Tests
Bio-RAD Laboratories, Inc.
25258
In Commercial Distribution

  • 00847865001847 ()

  • 4800 Tests
25258

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests
Bio-RAD Laboratories, Inc.
32592
In Commercial Distribution

  • 00847865001830 ()

  • 960 Tests
32592

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests
Bio-RAD Laboratories, Inc.
32591
In Commercial Distribution

  • 00847865001823 ()

  • 480 Tests
32591

  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
aBs Anti-HBs Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483780
In Commercial Distribution

  • 00630414982182 ()
L2KAB2(D)

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Atellica IM HBcT2 (REF) 500T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11643118
In Commercial Distribution

  • 00630414637877 ()
11643118

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HBc Total 2 (HBcT2) Atellica IM - CLT 2 x 2 x 7.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200740
In Commercial Distribution

  • 00630414604336 ()
11200740

  • Hepatitis B virus core total antibody IVD, control
HBc Total 2 (HBcT2) Atellica IM - RGT 100T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11200739
In Commercial Distribution

  • 00630414604138 ()
11200739

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HBsAgII (HBsII) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995605
In Commercial Distribution

  • 00630414599281 ()
10995605

  • Hepatitis B virus surface antigen IVD, control
HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995604
In Commercial Distribution

  • 00630414599274 ()
10995604

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
10995600
In Commercial Distribution

  • 00630414599236 ()
10995600

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) QC Kit - Atellica IM - CLT 2 x 1 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995599
In Commercial Distribution

  • 00630414599229 ()
10995599

  • Hepatitis B virus e-antigen immunoglobulin G (IgG) antibody IVD, control
HBC Total Ab (HBcT) QC Kit - Atellica IM - CLT 2 x 2 x 15.0mL
Siemens Healthcare Diagnostics Inc.
10995598
In Commercial Distribution

  • 00630414599212 ()
10995598

  • Hepatitis B virus core total antibody IVD, control
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995597
In Commercial Distribution

  • 00630414599205 ()
10995597

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) QC Kit - Atellica IM - CLT 2 x 2 x 10.0 mL
Siemens Healthcare Diagnostics Inc.
10995454
In Commercial Distribution

  • 00630414597843 ()
10995454

  • Hepatitis B virus surface total antibody IVD, control
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
10995453
In Commercial Distribution

  • 00630414597836 ()
10995453

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) QC Kit - Atellica IM - CTL 2 x 2 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10995450
In Commercial Distribution

  • 00630414597805 ()
10995450

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995449
In Commercial Distribution

  • 00630414597799 ()
10995449

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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