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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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AvertD™ Amplification Mix - 10850009370195

The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-3560-01
In Commercial Distribution

  • 10850009370195 ()
  • 30850009370199 ()
03-3560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)

Epi proColon - 04260400670029

Epi proColon Control Kit
Epigenomics AG
Control Kit
In Commercial Distribution

  • 04260400670029 ()
M5-02-003

  • Methylated DNA IVD, kit, nucleic acid technique (NAT)

Epi proColon - 04260400670012

Epi proColon Sensitive PCR Kit
Epigenomics AG
Sensitive PCR Kit
In Commercial Distribution

  • 04260400670012 ()
M5-02-002

  • Methylated DNA IVD, kit, nucleic acid technique (NAT)

Aptima® - 15420045506763

Aptima® HBV Quant Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HBV, VL, US IVD
In Commercial Distribution

  • 15420045506763 ()
PRD-03869

  • Hepatitis B virus nucleic acid IVD, control

Aptima® - 15420045506756

Aptima® HBV Quant Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HBV VL, US IVD
In Commercial Distribution

  • 15420045506756 ()
PRD-03872

  • Hepatitis B virus nucleic acid IVD, calibrator

Alinity m - 00884999048621

Alinity m HR HPV CTRL Kit
ABBOTT MOLECULAR INC.
09N15-085
In Commercial Distribution

  • 00884999048621 ()
09N15-085

  • Human papillomavirus (HPV) high-risk strain nucleic acid IVD, control

Alinity m - 00884999047815

Alinity m HBV CTRL Kit
ABBOTT MOLECULAR INC.
08N47-085
In Commercial Distribution

  • 00884999047815 ()
08N47-085

  • Hepatitis B virus nucleic acid IVD, control

Alinity m - 00884999047808

Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator

RealTime - 00884999047358

Abbott RealTime IDH1 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08N90-090
In Commercial Distribution

  • 00884999047358 ()
08N90-090

  • Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD, kit, nucleic acid technique (NAT)

RealTime - 00884999047341

Abbott RealTime IDH1 Control Kit
ABBOTT MOLECULAR INC.
08N90-080
In Commercial Distribution

  • 00884999047341 ()
08N90-080

  • Isocitrate dehydrogenase 1 (IDH1) gene mutation IVD, control
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