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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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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® 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 BKV AMP Kit
ABBOTT MOLECULAR INC.
09N85-095
In Commercial Distribution

  • 00884999050709 ()
09N85-095

  • BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m BKV CTRL Kit
ABBOTT MOLECULAR INC.
09N85-085
In Commercial Distribution

  • 00884999050686 ()
09N85-085

  • BK virus (BKV) nucleic acid IVD, control
Alinity m BKV CAL Kit
ABBOTT MOLECULAR INC.
09N85-075
In Commercial Distribution

  • 00884999050662 ()
09N85-075

  • BK virus (BKV) nucleic acid IVD, calibrator
No Description
Fujirebio Europe
81663
In Commercial Distribution

  • 05414470816637 ()

  • Number of tests per kit = 100


  • Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Fujirebio Europe
81660
In Commercial Distribution

  • 05414470816606 ()

  • Number of tests per kit = 40


  • Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)
The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US) instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228035725 ()
874821

  • BRAF gene mutation IVD, kit, nucleic acid technique (NAT)
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
FUJIREBIO INC.
235454
In Commercial Distribution

  • 04987270235454 ()

  • 4 Bottles per unit; 1.5mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
LMA ProSeal™ Size 5
TELEFLEX INCORPORATED
IPN929454
In Commercial Distribution

  • 30801902154119 ()
  • 20801902154112 ()
  • 10801902154115 ()

  • Size 5
150050

  • Laryngeal mask airway, reusable
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