FDA.reportPublic FDA data

BioCode MDx 3000

Primary DI
00851034007004
Brand
BioCode MDx 3000
Company
APPLIED BIOCODE, INC.
Model
1
Catalog number
41-A0051
Device description
The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.
Published
2018-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00851034007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851034007004008510340070048510340070040851034007004

GMDN Terms#

Term, Definition table
TermDefinition
Microplate reader IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5628010050tpham@apbiocode.com

Regulatory Flags#

DUNS number
004580003
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851034007028BioCode MDx 3000 Optical Calibration and Verification Kit164-C00022019-07-30
00851034007073BioCode Respiratory Pathogen Panel0163-R00012020-01-10
00851034007011Gastrointestinal Pathogen Panel (GPP) Kit12018-10-15
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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