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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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Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z1-4) - 00810118104015

Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z1-4)
NUSMILE, LTD.
ZBS25APRO4
In Commercial Distribution

  • 00810118104015 ()


  • Rotary/reciprocating endodontic file/rasp, single-use

Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z1-4) - 00810118104008

Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z1-4)
NUSMILE, LTD.
ZBS21APRO4
In Commercial Distribution

  • 00810118104008 ()


  • Rotary/reciprocating endodontic file/rasp, single-use

Adjustable Torque Wrench (for BioHorizons) - E219BIOTORQ1

Adjustable Torque Wrench (for BioHorizons)
ALTATEC GmbH
BIOTORQ
In Commercial Distribution

  • E219BIOTORQ1 ()
  • E219BZ53201030300 ()
BZ5320.1030

  • Dental torque wrench

ANTI-CD45RO (T-CELL) - 00810119677150

No Description
BIOGENEX LABORATORIES
AX113-YCD
In Commercial Distribution

  • 00810119677150 ()
AX113-YCD

  • CD45RO cell marker IVD, antibody

ANTI-P16(INK4) - 00810119675446

No Description
BIOGENEX LABORATORIES
MU540-UC
In Commercial Distribution

  • 00810119675446 ()

  • Total Volume: 1 Milliliter
MU540-UC

  • p16 antigen IVD, antibody

One+Step 10A - 08806141303497

One device is included 100 test strips
DFI CO.,LTD
30D4
Not in Commercial Distribution

  • 08806141303497 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

One+Step Uric Acid - 08806141303077

No Description
DFI CO.,LTD
31H0P
Not in Commercial Distribution

  • 08806141303077 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Just Fitter 10 Parameter Test Strips - 08806141302209

The one device that has DI number included 100 strips
DFI CO.,LTD
30C4
Not in Commercial Distribution

  • 08806141302209 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

CYBOW 10 - 08806141302070

The one device that has DI number included 100 strips
DFI CO.,LTD
0004
In Commercial Distribution

  • 08806141302070 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Yodoc 10 - 08806141301998

The one device that DI number included 100 strips
DFI CO.,LTD
0024
In Commercial Distribution

  • 08806141301998 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

QTEST™ 11 - 08806141301479

The one device that has DI number included 100 strips.
DFI CO.,LTD
0994
In Commercial Distribution



  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

CYBOW 11 - 08806141300755

QTEST™ 11
DFI CO.,LTD
0A94
In Commercial Distribution

  • 08806141300755 ()
  • 08806141300793 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

UCARE 11 Stick - 08806125680286

Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity), Leucocytes and Ascorbic acid in urine.
YD Diagnostics CORP.
P412
In Commercial Distribution

  • 08806125680286 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

UCARE 11 Stick - 08806125680279

Urinalysis dip and read strips for urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) , Leucocytes and Ascorbic acid in urine.
YD Diagnostics CORP.
P411
In Commercial Distribution

  • 08806125680279 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

URiSCAN 10 SGL strip - 08806125680217

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Leucocytes, Nitrite, Urobilinogen, Glucose, pH, Blood, SG(Specific Gravity), Ketones(Acetoacetic Acid), Bilirubin and Protein in urine.
YD Diagnostics CORP.
U774
In Commercial Distribution

  • 08806125680217 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

URiSCAN 10 SGL strip - 08806125680019

Urinalysis dip and read strips for visual and URiSCAN urine analyzer. Test for Blood, Bilirubin, Urobilinogen, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity) and Leucocytes in urine.
YD Diagnostics CORP.
U391
In Commercial Distribution

  • 08806125680019 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Aspergillus fumigatus IgG ELISA - 04048474061291

The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-6129
In Commercial Distribution

  • 04048474061291 ()
EIA-6129

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Ascaris IgG ELISA - 04048474058543

For the qualitative screening of serum or plasma IgG antibodies to Ascaris using an Enzyme Linked Immunoabsorbant Assay (ELISA) technique.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5854
In Commercial Distribution

  • 04048474058543 ()
EIA-5854

  • Ascaris lumbricoides immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Androstenedione - 04048474053395

The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
HYE-5339
In Commercial Distribution

  • 04048474053395 ()
HYE-5339

  • Androstenedione IVD, kit, enzyme immunoassay (EIA)

Vitamin C (Ascorbic Acid) - 04048474048889

This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, serum and urine.
DRG Instruments Gesellschaft mit beschränkter Haftung
ENZ-4888
In Commercial Distribution

  • 04048474048889 ()
ENZ-4888

  • Vitamin C (ascorbic acid) IVD, reagent

GAD65 Ab ELISA - 04048474040876

The GAD65 Autoantibody (GAD Ab) ELISA kit is intended for use by professional persons only, for the quantitative determination of GAD Ab in human serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4087
In Commercial Distribution

  • 04048474040876 ()
EIA-4087

  • Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)

ACTH (Adrenocorticotropic Hormone) ELISA - 04048474036473

The DRG ACTH ELISA is intended for the quantitative determination of ACTH (Adreno-corticotropic Hormone) in human plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3647
In Commercial Distribution

  • 04048474036473 ()
EIA-3647

  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)

Anti-Cardiolipin Screen ELISA - 04048474035896

Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3589
Not in Commercial Distribution

  • 04048474035896 ()
EIA-3589

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Cardiolipin IgA ELISA - 04048474035889

Anti-Cardiolipin IgA ELISA is a test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3588
In Commercial Distribution

  • 04048474035889 ()
EIA-3588

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Anti-Cardiolipin IgG/IgM ELISA - 04048474035872

Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3587
In Commercial Distribution

  • 04048474035872 ()
EIA-3587

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Adenovirus IgG ELISA - 04048474034462

The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3446
In Commercial Distribution

  • 04048474034462 ()
EIA-3446

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Adenovirus Antigen (stool) ELISA - 04048474034448

The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3444
Not in Commercial Distribution

  • 04048474034448 ()
EIA-3444

  • Adenovirus antigen IVD, kit, enzyme immunoassay (EIA)

Androstenedione ELISA - 04048474032659

The DRG Androstenedione ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum and EDTA plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3265
In Commercial Distribution

  • 04048474032659 ()
EIA-3265

  • Androstenedione IVD, kit, enzyme immunoassay (EIA)

Cardiolipin IgA ELISA - 04048474027907

The Cardiolipin IgA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative measurement of circulating IgA autoantibodies to Cardiolipin
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2790
In Commercial Distribution

  • 04048474027907 ()
EIA-2790

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Cardiolipin IgM ELISA - 04048474027891

The Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi- quantitative measurement of circulating IgM autoantibodies to Cardiolipin
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2789
In Commercial Distribution

  • 04048474027891 ()
EIA-2789

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
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