The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays. The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.

The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real
DSQ Alert Internal Control set IC1 - M800734

A defined piece of single-stranded nucleic acid intended to be used to initiate the amplification of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, using a nucleic acid amplification technique (e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)]. It is typically used to detect and/or identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OLD

Device Name: Internal Polymerase Chain Reaction Control, Not Assay Specific

Device Class: 1

Physical State: It is a nonsense, non-specific deoxyribonucleic acid (DNA) sequence cloned into a plasmid vector and supplied in a tris ethylenediaminetetraacetic acid buffer.

Definition: Internal control that can be 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.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The internal control template is a synthetic deoxyribonucleic acid (DNA) sequence that can be added to samples prior to nucleic acid extraction. With the addition of specific primer and probe sets, it is then amplified along with the target DNA sequence during the real-time polymerase chain reaction (PCR) process.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: It is for in vitro diagnostic tests.

Regulation Number: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Id: 03661540952791

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