Gastrointestinal Pathogen Panel (GPP) Kit

GUDID 00851034007011

In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.

APPLIED BIOCODE, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00851034007011
NIH Device Record Keyf7228397-ce95-4208-a64b-771fc91e01b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGastrointestinal Pathogen Panel (GPP) Kit
Version Model Number1
Company DUNS004580003
Company NameAPPLIED BIOCODE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com
Phone562-801-0050
Emailtpham@apbiocode.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851034007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-15
Device Publish Date2018-10-15

Devices Manufactured by APPLIED BIOCODE, INC.

00851034007073 - BioCode Respiratory Pathogen Panel2020-01-20 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
00851034007028 - BioCode MDx 3000 Optical Calibration and Verification Kit2019-08-07 Kit containing calibrators and controls for MDx 3000.
00851034007035 - BioCode MDx 3000 Buffer A2019-08-07 Buffer used in MDx 3000 assays.
00851034007042 - BioCode SA-PE Mix Pack2019-08-07 Fluorescence dye for MDx 3000 assays.
00851034007004 - BioCode MDx 30002018-11-15 The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB)
00851034007011 - Gastrointestinal Pathogen Panel (GPP) Kit2018-11-15In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
00851034007011 - Gastrointestinal Pathogen Panel (GPP) Kit2018-11-15 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
00851034007059 - BioCode 2500 Multiplex Detection System2018-09-24 The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magneti

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