AccessGUDID - DEVICE: BioCode MDx 3000 (00851034007004)

GUDID

Device Identifier (DI) Information

Brand Name: BioCode MDx 3000
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 41-A0051
Company Name: APPLIED BIOCODE, INC.

Primary DI Number: 00851034007004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004580003 *Terms of Use

Device Description: The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57862	Microplate reader IVD, automated/semi-automated	An electrically-powered automated or semi-automated 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	Real Time Nucleic Acid Amplification System
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180041	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85a52091-6381-461b-a61c-ae3f412836bb
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: October 15, 2018