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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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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

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

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
ACON LABORATORIES, INC.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

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

Rapid Response - 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


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

CARDINAL HEALTH - 10195594837150

PAIN TRAY
Cardinal Health 200, LLC
34-6921H
In Commercial Distribution

  • 50195594837158 ()
  • 10195594837150 ()
34-6921H

  • Orthopaedic cement, antimicrobial

Biomeme SARS-CoV-2 Go-Plates - 00810096640093

Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640090 ()
  • 00810096640093 ()
3000634

  • Nucleic acid amplification mastermix reagent IVD

Biomeme RNA Process Control (RPC) Kiit - 00810096640079

RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640076 ()
  • 00810096640079 ()
3000627

  • Exogenous DNA/RNA internal control IVD, kit

Biomeme SARS-CoV-2 Go-Strips - 00810096640055

Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640052 ()
  • 00810096640055 ()
3000633

  • Nucleic acid amplification mastermix reagent IVD

WELLlife™ - 00816862026863

WELLlife™ COVID-19/Influenza A&B Test Cassette, 25 Tests per Kitbox
WONDFO USA CO., LTD.
WV01P0002-S
In Commercial Distribution

  • 10816862026860 ()
  • 00816862026863 ()
  • 00816862026856 ()


  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical

Universal ZGO Densah Bur Holder - 00850017652781

Universal Densah Bur Holder is a holder for the ZGO Densah Burs and ZGO Guided Keys, ZGO Tapered Pilot Drill
VERSAH, LLC
ZBLK
In Commercial Distribution

  • 00850017652781 ()


  • Surgical instrument interim-placement holder, reusable
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