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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-3 P
Not in Commercial Distribution

  • 04049016053170 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-3 P
Not in Commercial Distribution

  • 04049016053163 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-3 P
Not in Commercial Distribution

  • 04049016053156 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1003-3 P
Not in Commercial Distribution

  • 04049016053149 ()


  • Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000319954
In Commercial Distribution

  • 00810000319954 ()


  • Adhesive bandage
Blister Support Bandage Cushion
HRA PHARMA AMERICA, INC.
00810000310081
In Commercial Distribution

  • 00810000310081 ()


  • Adhesive bandage
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
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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