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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Cleaning solution for Miris Human Milk Analyzer™. Concentrate, 50 mL. Dilute the content with 950 mL distilled or deionized water and mix. Warm to 35-40°C before use.
Miris AB
39-04-001
In Commercial Distribution

  • 07350107530034 ()

  • Total Volume: 50 Milliliter
39-04-001

  • Wash/cleaning solution IVD, manual equipment
Zero-setting solution for Miris Human Milk Analyzer™. Concentrate, 10 mL. Dilute the content with 90 mL distilled or deionized water and mix. Warm to 35-40° C before use.
Miris AB
39-01-003
In Commercial Distribution

  • 07350107530027 ()

  • Total Volume: 10 Milliliter
39-01-003

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5135
In Commercial Distribution

  • 05060169691070 ()


  • Progesterone IVD, calibrator
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5130
In Commercial Distribution

  • 05060169690882 ()


  • Progesterone IVD, control
DSQ Alert™ HT Candida auris Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 124 bp region of the ITS2 gene of Candida auris.
Elitechgroup Mdx LLC
M800760
In Commercial Distribution

  • 03661540952562 ()
M800760

  • Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
800416
In Commercial Distribution

  • 03661540951503 ()
800416

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
MGB Alert® HSV 1 & 2 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2.
Elitechgroup Mdx LLC
800354
In Commercial Distribution

  • 03661540951381 ()
800354

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
DSQ Alert Enterovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the enterovirus RNA genome. The mix consists of a total of 14.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 138 bp region of the 5’-UTR of enterovirus.
Elitechgroup Mdx LLC
M800708
In Commercial Distribution

  • 03661540952104 ()
M800708

  • Enterovirus nucleic acid (serotypes 68-71) IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HSV Typer AS Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from HSV 1 and 2 (Herpes Simplex Virus 1 & 2). The mix consists of a total of 1.0 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 54 nucleic acid sequence from the glycoprotein D region of HSV 1 and 2."
Elitechgroup Mdx LLC
800518
In Commercial Distribution

  • 03661540951688 ()
800518

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
Product Name: Start Kit This product is a customized Start Kit that one content of the kit was replaced with the other product comparing to the ordinary Start Kit. It includes Light Body 1 EA, Heavy Body 1 EA, Putty 1 EA, Yellow Mix Tip 3 EA, Intra Oral Tip 3 EA & Green Mix Tip 3 EA instead of the contents of ordinary Start Kit(NSSK).
NEOSIL Co., Ltd
NSSK-1
In Commercial Distribution

  • 18800026400063 ()
  • 08800026400066 ()


  • Dental impression material kit, single-use
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