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The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.
LUMINEX CORPORATION
3711
Not in Commercial Distribution
- 00840487101032 ()
3711
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of
respiratory tract infections
Luminex Molecular Diagnostics, Inc
I025C0197
Not in Commercial Distribution
- 00840487100486 ()
I025C0197
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens
Luminex Molecular Diagnostics, Inc
I006C0068
Not in Commercial Distribution
- 00840487100455 ()
I006C0068
- Cystic fibrosis IVD, kit, multiplex
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3806
In Commercial Distribution
- 00840487100127 ()
3806
- Endogenous RNA internal control reagent IVD
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
03-7560-01
In Commercial Distribution
- 30850009370250 ()
- 10850009370256 ()
03-7560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution
- 30850009370243 ()
- 10850009370249 ()
03-6560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
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)
Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.
LUMINEX CORPORATION
3805
In Commercial Distribution
- 00840487101414 ()
3805
- Endogenous RNA internal control reagent IVD
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3920
In Commercial Distribution
- 00840487101407 ()
3920
- Trichomonas vaginalis nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3919
In Commercial Distribution
- 00840487101391 ()
3919
- Multiple Candida species nucleic acid IVD, reagent