"MGB Alert® B. pertussis / B. parapertussis Probe Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed
to detect nucleic acid sequences from the insertion sequence IS481 in Bordetella pertussis and insertion sequence IS1001 in Bordetella parapertussis.
The mix consists of two probes at 1.12 nmol per vial in a 1X TE buffer solution. The probes are labeled with 6
MGB Alert® Bordetella P/PP Probe Mix ASR - 48 Reactions - 800438
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Bordetella pertussis in a clinical specimen, using a nucleic acid technique (NAT). The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.
Environmental Conditions
- -10.00
- N/A
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MVU
Device Name: Reagents, Specific, Analyte
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.4020
Third Party Flag: N
Medical Specialty: PA
Device IdentifiersDevice Id: 03661540951886
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