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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ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0
ORTHO-CLINICAL DIAGNOSTICS, INC.
715280
In Commercial Distribution

  • 10758750003389 ()
715280

  • Anti-Le^a red blood cell grouping IVD, antibody
ANTI-FYA (ANTI-DUFFY A) 1X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
715130
In Commercial Distribution

  • 10758750003365 ()
715130

  • Anti-Fy^a red blood cell grouping IVD, antibody
Group A Latex Reagent
PRO-LAB, INCORPORATED
PL.1031
In Commercial Distribution

  • 10628429001322 ()
PL.1031

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
A range of accessory products to complement the Prolex™ Staph Latex group of products.
PRO-LAB, INCORPORATED
PL.092-48
In Commercial Distribution

  • 10628429000370 ()
PL.092-48

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Mixing Sticks
PRO-LAB, INCORPORATED
PL.091P
In Commercial Distribution

  • 10628429000356 ()
PL.091P

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Victory ™ - 00816349012419
BRIVANT LIMITED
Victory 14 (195 cm, 30g)
In Commercial Distribution

  • 00816349012419 ()
H74939471195300

  • Mycobacterium tuberculosis immunoglobulin A (IgA) antibody IVD, reagent
QMol FLUA+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M106
In Commercial Distribution

  • 30014613311065 ()
M106

  • Influenza A/B virus nucleic acid IVD, control
Solana Flu A+B Control Set
DIAGNOSTIC HYBRIDS, INC.
M122
In Commercial Distribution

  • 30014613336990 ()
M122

  • Influenza A/B virus nucleic acid IVD, control
No Description
MONOBIND, INC.
725-300
In Commercial Distribution

  • 00816870021027 ()

  • Width: 7.75 Inch
725-300A

  • Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay
Group A Strep (GAS) Primers ASR.
Hologic, Inc.
DNA GAS PRIMERS (ASR)
In Commercial Distribution

  • 15420045511590 ()
PRD-05050

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Group A Strep (GAS) Probe ASR.
Hologic, Inc.
DNA GAS PROBE (ASR)
In Commercial Distribution

  • 15420045511576 ()
PRD-05051

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, reagent
Hologic GAS Plasmid Control.
Hologic, Inc.
LBLD, GAS PLASMID (UNASSAYED CONTROL)
In Commercial Distribution

  • 15420045511552 ()
PRD-05052

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) (13643B9) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual tube method.
DIAGAST
210541
In Commercial Distribution

  • 23661562105414 ()
210541

  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal) (P3HT7) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual tube method.
DIAGAST
210534
In Commercial Distribution

  • 23661562105346 ()
210534

  • Anti-Jk^a red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal) (IgG) (DG-FYA-02) - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual tube method.
DIAGAST
210531
In Commercial Distribution

  • 23661562105315 ()
210531

  • Anti-Fy^a red blood cell grouping IVD, antibody
No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
Mercodia Lp(a) ELISA provides a method for the quantitative determination of human Lp(a) in serum or plasma.
Mercodia AB
10-1106-01
In Commercial Distribution

  • 07350108630016 ()
10-1106-01

  • Lipoprotein Lp(a) IVD, kit, enzyme immunoassay (EIA)
No Description
Microgenics Corporation
100012
In Commercial Distribution

  • 00884883001299 ()


  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Blood Grouping Reagent Anti-Lea (LE1); Seraclone® Murine Monoclonal (LEA2); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808403100
In Commercial Distribution

  • 07611969951970 ()
808403100

  • Anti-Le^a red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-Fya (FY1); Seraclone® Human Monoclonal (DG-FYA-02); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808188100
In Commercial Distribution

  • 07611969951833 ()
808188100

  • Anti-Fy^a red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-Jka (JK1); Seraclone® Human Monoclonal (MS15); for tube test; 2ml
Bio-Rad Medical Diagnostics GmbH
808179100
In Commercial Distribution

  • 07611969951758 ()
808179100

  • Anti-Jk^a red blood cell grouping IVD, antibody
QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel
MICROBIOLOGICS INC.
8219
In Commercial Distribution

  • 70845357041493 ()
8219

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control
No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution

  • 00608337000054 ()


  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution

  • 10743816001492 ()
BSP-510C-03

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution

  • 10743816001423 ()
BSP-510C-02

  • Nasopharyngeal aspirate container IVD
  • Influenza A/B virus antigen IVD, reagent
  • Influenza A/B virus antigen IVD, control
Modern Fertility Pregnancy Test 4ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599634 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599627 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Modern Fertility Pregnancy Test 2ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599610 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233118 ()


  • Radiology DICOM image processing application software
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233101 ()


  • Radiology DICOM image processing application software
No Description
A1 SURGICAL SUPPLIES, LLC
A
In Commercial Distribution

  • 50860000082803 ()
  • 00860000082808 ()


  • Suction/irrigation tubing, single-use
InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755999 ()
ASY-300143

  • General/multiple surgical laser system beam guide, reusable
InnoVoyce VYLO 30W 455nm Laser
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755982 ()
ASY-300134

  • General/multiple surgical diode laser system
InnoVoyce Laser Fiber .600 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755975 ()
  • 00860004755944 ()
ASY-300063-600

  • General/multiple surgical solid-state laser system
InnoVoyce Laser Fiber .400 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755968 ()
  • 00860004755937 ()
ASY-300063-400

  • General/multiple surgical solid-state laser system
InnoVoyce Laser Fiber .300 1 Pack
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755951 ()
  • 00860004755920 ()
ASY-300063-300

  • General/multiple surgical solid-state laser system
KTP Laser Fiber 600
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755913 ()
  • 10860004755903 ()

  • Outer Diameter: 600 Micrometer
KLF-001-600

  • General/multiple surgical laser system beam guide, single-use
KTP Laser Fiber 400
Innovoyce LLC
A
In Commercial Distribution

  • 00860004755906 ()
  • 20860004755900 ()

  • Outer Diameter: 400 Micrometer
KLF-001-400

  • General/multiple surgical laser system beam guide, single-use
No Description
PARKER-HANNIFIN CORPORATION
A
In Commercial Distribution

  • 00860002624914 ()
  • 00860002624921 ()


  • Ventricular cerebrospinal fluid drainage catheterization kit
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
InnoVoyce VYLO Cart
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812180 ()
LC-00455

  • General/multiple surgical diode laser system
InnoVoyce VYLO Eye Safety Filter Zeiss
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812104 ()
ASY-300144

  • General/multiple surgical diode laser system
InnoVoyce VYLO Footswitch
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812111 ()
PRT-301009

  • General/multiple surgical diode laser system
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008263 ()
991066S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution

  • 00868924000038 ()


  • Short-wave diathermy treatment system, home-use
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450295608 ()
  • 00884450295601 ()

  • Catheter Length Tip-Cuff (cm)-31 cm
  • French Size (F)-15F
CENFT31K

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450295530 ()
  • 00884450295533 ()

  • French Size (F)-15F
  • Catheter Length Tip-Cuff (cm)-19 cm
CENFT19C

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450021344 ()
  • 00884450021347 ()
  • 20884450021341 ()
IN9802

  • Catheter/overtube balloon inflator, single-use
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