FDA.reportPublic FDA data

Gastrointestinal Pathogen Panel (GPP) Kit

Primary DI
00851034007011
Brand
Gastrointestinal Pathogen Panel (GPP) Kit
Company
APPLIED BIOCODE, INC.
Model
1
Device description
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
Published
2018-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180041000BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.2018-09-28PCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851034007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851034007011008510340070118510340070110851034007011

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
562-801-0050tpham@apbiocode.com

Regulatory Flags#

DUNS number
004580003
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851034007004BioCode MDx 3000141-A00512018-10-15
00851034007028BioCode MDx 3000 Optical Calibration and Verification Kit164-C00022019-07-30
00851034007073BioCode Respiratory Pathogen Panel0163-R00012020-01-10
00851034007035BioCode MDx 3000 Buffer A12019-07-30
00851034007042BioCode SA-PE Mix Pack12019-07-30
00851034007059BioCode 2500 Multiplex Detection System141-A00052018-08-22

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