AvertD™ Intellipac Reagent Module 03-2560-01

GUDID 10850009370201

The Intellipac 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

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Primary Device ID10850009370201
NIH Device Record Key039d3381-73cb-4d0e-93ee-80692c4c6dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameAvertD™ Intellipac Reagent Module
Version Model Number03-2560-01
Catalog Number03-2560-01
Company DUNS027914535
Company NameAUTOGENOMICS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com
Phone760-477-2248
Emailtechsupport@autogenomics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110850009370201 [Primary]
GS130850009370205 [Package]
Package: Box [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

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10850009370201 - AvertD™ Intellipac Reagent Module2024-06-10 The Intellipac Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer
10850009370218 - AvertD™ BioFilmChip Microarray Magazine2024-06-10 The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis
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00850009370020 - INFINITI® High Throughput System (HTS) PROCESSOR2019-10-31 Instrumentation For Clinical Multiplex Test Systems
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Trademark Results [AvertD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AVERTD
AVERTD
90018312 not registered Live/Pending
Prescient Medicine Holdings, Inc.
2020-06-24
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