AccessGUDID - DEVICE: BioCode Respiratory Pathogen Panel (00851034007073)

GUDID

Device Identifier (DI) Information

Brand Name: BioCode Respiratory Pathogen Panel
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 63-R0001
Company Name: APPLIED BIOCODE, INC.

Primary DI Number: 00851034007073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004580003 *Terms of Use

Device Description: In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
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?
61317	Multiple-type respiratory pathogen nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., viruses and bacteria) associated with respiratory disease and/or multiple genes conferring antimicrobial resistance in microorganisms present in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems
OZZ	Bordetella Pertussis Dna Assay System
OZY	Chlamydophila Pneumoniae Dna Assay System
OZX	Mycoplasma Pneumoniae Dna Assay System
OTG	Non-Sars Coronavirus Multiplex Nucleic Acid Assay
OOU	Parainfluenza Multiplex Nucleic Acid Assay
OEM	Human Metapneumovirus (Hmpv) Rna Assay System
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OCC	Respiratory Virus Panel Nucleic Acid Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192485	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 -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86169df7-c0b5-496c-8036-508b9418e7f5
Public Version Date: December 21, 2020
Public Version Number: 2
DI Record Publish Date: January 10, 2020