AccessGUDID - DEVICE: Simplexa™ Bordetella Direct (20816101025620)

GUDID

Device Identifier (DI) Information

Brand Name: Simplexa™ Bordetella Direct
Version or Model: MOL2750
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MOL2750
Company Name: DIASORIN MOLECULAR LLC

Primary DI Number: 20816101025620
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 080271715 *Terms of Use

Device Description: Simplexa™ Bordetella Direct

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:	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?
58957	Multiple respiratory disease-associated bacteria 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 bacteria associated with upper and/or lower respiratory disease, which may include multiple genes conferring resistance to antimicrobial drugs, in a clinical specimen using a nucleic acid technique (NAT). Bacteria detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, Chlamydia pneumonia, Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZZ	Bordetella Pertussis Dna Assay System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173498	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: 9e7709be-0d1d-4f9c-bb55-ef8686019cc7
Public Version Date: July 08, 2024
Public Version Number: 3
DI Record Publish Date: August 24, 2018