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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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Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test System - B110VZ70120

No Description
Bion Enterprises, Ltd.
VZ-7012
In Commercial Distribution

  • B110VZ70120 ()
VZ-7012

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, reagent
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, reagent

Mycoplasma pneumoniae Antigen Substrate, 12 wells, For IFA Test System - B110MP12120

No Description
Bion Enterprises, Ltd.
MP-1212
In Commercial Distribution

  • B110MP12120 ()
MP-1212

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, reagent

Mycoplasma pneumoniae Antigen Substrate, 6 wells, For IFA Test System - B110MP12060

No Description
Bion Enterprises, Ltd.
MP-1206
Not in Commercial Distribution

  • B110MP12060 ()
MP-1206

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, reagent

Herpes Simplex Negative Control - B110HSN35100

No Description
Bion Enterprises, Ltd.
HSN-3510
In Commercial Distribution

  • B110HSN35100 ()
HSN-3510

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Diamedix - 00817273020044

"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
DIAMEDIX CORPORATION
300-371A
In Commercial Distribution

  • 00817273020044 ()


  • Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)

ACCURUN® - 00816784020147

ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control

ACCURUN® - 00816784020130

ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0034
In Commercial Distribution

  • 00816784020130 ()
2000-0034

  • Multiple infectious organism/newborn TORCH screen IVD, control

CARDINAL HEALTH - 20885380020282

H.pylori Rapid Test
Cardinal Health 200, LLC
B1077-25
Not in Commercial Distribution

  • 50885380020283 ()
  • 20885380020282 ()
  • 10885380020285 ()
B1077-25

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

EasyFlow Duo Cannula - 00803622128073

No Description
LIVANOVA USA, INC.
Duo Cannula
In Commercial Distribution

  • 10803622128070 ()
  • 00803622128073 ()


  • Aorta cannula

Amplatzer™ - 00811806011530

Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter

PRO ADVANTAGE - M220P0800953

PRO ADVANTAGE H PYLORI TEST TUBES 20TST/KT
NATIONAL DISTRIBUTION & CONTRACTING, INC.
P080095
In Commercial Distribution

  • M220P0800955 ()
  • M220P0800953 ()
P080095

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Lyher - 06972412619405

The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is a lateral flow immunoassay intended for the qualitative detection of and differentiation of IgG and IgM antibodies to SARS-CoV-2 in serum and plasma (dipotassium-EDTA, lithium-heparin, or sodium-citrate). The LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicatingrecent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests.
Hangzhou Laihe Biotech Co.,Ltd.
303002
In Commercial Distribution

  • 06972412619405 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit - 06973774259803

No Description
Biohit Healthcare (Hefei) Co., Ltd.
25 Tests/Kit
In Commercial Distribution

  • 06973774259803 ()
  • 16973774259800 ()
REF:207.01.25.02

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Fastep COVID-19 IgG/IgM Rapid Test Device - 06952804805029

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804805029 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327683153

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ908719B
In Commercial Distribution

  • 40195327683154 ()
  • 10195327683153 ()
DYNJ908719B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327155902

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ908719
In Commercial Distribution

  • 40195327155903 ()
  • 10195327155902 ()
DYNJ908719

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327460846

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ908719A
In Commercial Distribution

  • 40195327460847 ()
  • 10195327460846 ()
DYNJ908719A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942908639

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ904995A
In Commercial Distribution

  • 10889942908639 ()
DYNJ904995A

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327165680

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ904995G
In Commercial Distribution

  • 10195327165680 ()
DYNJ904995G

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327141110

DR G ILESI
MEDLINE INDUSTRIES, INC.
PAIN1812
In Commercial Distribution

  • 40195327141111 ()
  • 10195327141110 ()
PAIN1812

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327116668

TRIPOINT SHOULDER G
MEDLINE INDUSTRIES, INC.
DYNJ904995F
In Commercial Distribution

  • 10195327116668 ()
DYNJ904995F

  • General surgical procedure kit, non-medicated, single-use

CEKA & PRECI-LINE ATTACHMENTS - 14260576941760

* CEKA SOL G
Alphadent NV
CS20
In Commercial Distribution

  • 04260576941763 ()
  • 14260576941760 ()

  • Outer Diameter: 1.15 Millimeter
  • tube solder
CS20

  • Dental brazing alloy

Barco - 05415334004733

MDSC-8258 MNA G
Barco NV
MDSC-8258
In Commercial Distribution

  • 05415334004733 ()
991932204032

  • Image display unit, colour

4all - DIVO578942AN1

4all 1000 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
578942AN
Not in Commercial Distribution

  • DIVO578942AN1 ()
578942AN

  • Dental casting non-noble alloy

4all - DIVO578891AN1

4all 250 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
578891AN
Not in Commercial Distribution

  • DIVO578891AN1 ()
578891AN

  • Dental casting non-noble alloy

HMRS - 04546540276520

G I-II. CIRCLIPS
Howmedica Osteonics Corp.
6466-9-230
In Commercial Distribution

  • 04546540276520 ()
6466-9-230

  • Uncoated knee tibia prosthesis, metallic

KLOCKNER - 08435451601179

EC G TRANSFER
SOADCO, S.L.
10 09 02 G
In Commercial Distribution

  • 08435451601179 ()
10 09 02 G

  • Dental implant suprastructure kit

i-STAT G Cartridge - 00054749005710

i-STAT G Cartridge
ABBOTT POINT OF CARE INC.
03P83-26
In Commercial Distribution

  • 10054749005717 ()
  • 00054749005710 ()
03P83-26

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Max G Handpiece - 00841494100278

Max G Handpiece
Cynosure, LLC
2520A-G046
In Commercial Distribution

  • 00841494100278 ()


  • Multi-modality skin surface treatment system
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