The Alethia™ C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the Alethia™ C. difficile test kit. External controls are used as part of a routine quality control program.
Alethia™ C. difficile External Control Kit - 479920
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OMN
Device Name: C. Difficile Nucleic Acid Amplification Test Assay
Device Class: 1
Physical State: kIt containing DNA positive control, DNA internal control, buffer containing deoxyribonucleic acids and magnesium chloride, DNA polymerase, DNA primers and DNA probes
Definition: In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Submission Type ID: 4
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Nucleic acid amplification test
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Stool samples
Regulation Number: 866.2660
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00840733102134
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A