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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The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes.
Elitechgroup Mdx LLC
M800689
In Commercial Distribution

  • 03661540951756 ()
M800689

  • Nucleic acid amplification mastermix kit IVD
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 66-02 I
In Commercial Distribution

  • D801ID6602I1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Paste / Liquid. Syringe. Non-Boxed. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 66-02 S
In Commercial Distribution

  • D801SP6602S1 ()
66-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
No Description
Dentsply International Inc.
644432
In Commercial Distribution

  • D0016444321 ()
644432

  • Solution agitator
  • Root canal ultrasonic irrigation handpiece tip
  • Medical equipment/instrument drape, single-use
No Description
Dentsply International Inc.
644431
In Commercial Distribution

  • D0016444311 ()
644431

  • Medical equipment/instrument drape, single-use
  • Root canal ultrasonic irrigation handpiece tip
  • Solution agitator
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)
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