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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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Trinity Biotech - 05391516747622

B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution

  • 05391516747622 ()
40-2023L

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Fungal Serology - 10634853000213

Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

CMV Negative Control - B110CMN20100

No Description
Bion Enterprises, Ltd.
CMN-2010
In Commercial Distribution

  • B110CMN20100 ()
CMN-2010

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Diamedix - 00817273020181

"720-350 HSV 1&2 IgM Test Kit"
DIAMEDIX CORPORATION
720-350
In Commercial Distribution

  • 00817273020181 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Diamedix - 00817273020167

"720-330 CMV IgM Test Kit"
DIAMEDIX CORPORATION
720-330
In Commercial Distribution

  • 00817273020167 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Medline Industries, Inc. - 10889942118205

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708B
In Commercial Distribution

  • 10889942118205 ()
DYNJ48708B

  • General surgical procedure kit, non-medicated, reusable

Medline Industries, Inc. - 10889942333790

G PACK
MEDLINE INDUSTRIES, INC.
DYNJ48708C
In Commercial Distribution

  • 10889942333790 ()
DYNJ48708C

  • General surgical procedure kit, non-medicated, reusable

i-STAT - 10054749000118

G CARTRIDGE
ABBOTT POINT OF CARE INC.
03P83-25
In Commercial Distribution

  • 10054749000118 ()
  • 00054749000111 ()
03P83-25

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

Leksell Stereotactic System - 07340201503263

FRAME G
Elekta Solutions AB
1040455
In Commercial Distribution

  • 07340201503263 ()
1040318

  • Neurological stereotactic surgery system

Vivid Nano Flow A 2 - D724D0102040

1 g
PEARSON DENTAL SUPPLIES, INC.
D010204
In Commercial Distribution

  • D724D0102040 ()


  • Light-cured dental restorative composite resin
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