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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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MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
INVITROCARE, INCORPORATED
2011-5
In Commercial Distribution

  • 00859268006169 ()
2011-5

  • IVF medium
MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
INVITROCARE, INCORPORATED
2011
In Commercial Distribution

  • 00859268006152 ()
2011

  • IVF medium
AccuDiag ™ Rubella IgM Enzyme- Linked Immunosorbent Assay (ELISA) is intended for the in vitro qualitative determination of IgM antibodies in human serum and as an aid in the diagnosis of current or recent infection with Rubella virus
Diagnostic Automation, Inc.
DACD1302-1
In Commercial Distribution

  • 00850049545693 ()

  • 96 tests
1302-1

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.
QUANTIMETRIX CORPORATION
5210-12
In Commercial Distribution

5210-12

  • Total protein IVD, reagent
An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection.
NANO-DITECH CORPORATION
MD8142
In Commercial Distribution

  • 00895160002465 ()
  • 10895160002462 ()
MD8142

  • Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical
Rheumatoid Factor Total is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
ORGENTEC Diagnostika GmbH
ORG522T
Not in Commercial Distribution

  • 04260157080263 ()
ORG522T

  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use
BIOSTONE CO. LIMITED
VET1201-O
In Commercial Distribution

  • 05060548020125 ()
VET1201-O

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
OBS1203
In Commercial Distribution

  • 05060548020101 ()
OBS1203

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe, They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box.
BIOSTONE CO. LIMITED
OBS1210
In Commercial Distribution

  • 05060548020019 ()
OBS1210

  • Bone matrix implant, synthetic, non-antimicrobial
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe, They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box.
BIOSTONE CO. LIMITED
SYS210
In Commercial Distribution

  • 05060548020538 ()
SYS210

  • Bone matrix implant, synthetic, non-antimicrobial
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