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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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MGB Alert Internal Control Set IC2-BH 48 rxn - 03661540950032

The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-BH can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800574
In Commercial Distribution

  • 03661540950032 ()
M800574

  • Exogenous DNA/RNA internal control IVD, kit

Macroduct® Advanced Supply Kit, w/o Dye, Qty 6 - 03661540304385

For use with Macroduct® Advanced Sweat Collection System to induce sweat for diagnosis of Cystic Fibrosis
ELITECHGROUP INC.
SS-268-ND
In Commercial Distribution

  • 03661540304385 ()


  • Sweat-induction iontophoresis system

Cavex Bite&White ABC Masterkit - E241BW0900

Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution

  • E241BW0900 ()

  • 1 pcs
BW090

  • Dental bleaching agent

Cavex Bite&White Ready 2 Use bulk - E241BW0350

Dental Whitening Agent
Cavex Holland B.V.
BW035
In Commercial Distribution

  • E241BW0350 ()

  • 1 pcs
BW035

  • Dental bleaching agent

Cavex Bite&White Ready 2 Use - E241BW0300

Dental Whitening Agent
Cavex Holland B.V.
BW030
In Commercial Distribution

  • E241BW0300 ()

  • 1 pcs
BW030

  • Dental bleaching agent

Cavex Bite&White bulk pack syringes - E241BW0150

Dental Whitening Agent
Cavex Holland B.V.
BW015
In Commercial Distribution

  • E241BW0150 ()

  • 1 pcs
BW015

  • Dental bleaching agent

Cavex Bite&White syringe - E241BW0100

Dental Whitening Agent
Cavex Holland B.V.
BW010
In Commercial Distribution

  • E241BW0100 ()

  • 1 pcs
BW010

  • Dental bleaching agent

Cavex Bite&White patient kit - E241BW0000

Dental Whitening Agent
Cavex Holland B.V.
BW000
In Commercial Distribution

  • E241BW0000 ()

  • 1 pcs
BW000

  • Dental bleaching agent

MGB Alert® BKV ASR v3.0 Primer Mix - 03661540952319

MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • Nucleic acid amplification primer IVD

MGB Alert Internal Control Set IC2-C -480 rxn QTY-100 - 03661540952302

The MGB Alert Internal Control Set IC2-C consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-C can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. QTY-100@480 reactions.
ELITECH GROUP INC.
800432-100
In Commercial Distribution

  • 03661540952302 ()
800432-100

  • Exogenous DNA/RNA internal control IVD, kit
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