AccessGUDID - DEVICE: MultiCode® Chlamydophila pneumoniae Primers (00840487100233)

GUDID

Device Identifier (DI) Information

Brand Name: MultiCode® Chlamydophila pneumoniae Primers
Version or Model: 3925
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3925
Company Name: LUMINEX CORPORATION

Primary DI Number: 00840487100233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079686463 *Terms of Use

Device Description: Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
43501	Multiple respiratory disease-associated bacteria nucleic acid IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria associated with upper and/or lower respiratory disease, which may include multiple genes conferring resistance to antimicrobial drugs, in a clinical specimen. Bacteria detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, Chlamydia pneumoniae, Fusobacterium necropherum, Arcanobacterium haemolyticum, Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	REAGENTS,SPECIFIC,ANALYTE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f51cdec-f14e-4bed-bf3e-84f1802250cc
Public Version Date: May 03, 2023
Public Version Number: 4
DI Record Publish Date: December 16, 2016