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
Lonza Verviers
BESP808D
In Commercial Distribution

  • 05407010121582 ()
BESP808D

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B1
In Commercial Distribution

  • 05407010121575 ()
BESP808B1

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP808B0.5
In Commercial Distribution

  • 05407010121568 ()
BESP808B0.5

  • Ex vivo cell culture medium
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012381
In Commercial Distribution

  • 00359883006525 ()

  • Total Volume: 380 Milliliter
012381

  • Silicone dental impression material
VPS Impression Tray Material
DEN-MAT HOLDINGS, LLC
012386
In Commercial Distribution

  • 00359883005986 ()

  • Total Volume: 380 Milliliter
012386

  • Silicone dental impression material
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.396
In Commercial Distribution

  • 04038917926713 ()
  • 04038917926690 ()
72.694.396

  • Assay container IVD, single-use
DSQ Alert BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus. The mix consists of a total of 6.4 nmol of primers per vial in a 1X TE buffer solution. The primers target a 72 bp region of the major capsid protein VP1 gene of the BK Virus. The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800726
In Commercial Distribution

  • 03661540952746 ()


  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ Candida auris Probe Mix ASR is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 of Candida auris.
Elitechgroup Mdx LLC
800730
In Commercial Distribution

  • 03661540952548 ()
800730

  • Assay development analyte-specific reagent IVD
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