AccessGUDID - DEVICE: Respiratory Pathogens Flex (RP Flex) Extraction Tray (00857573006263)

GUDID

Device Identifier (DI) Information

Brand Name: Respiratory Pathogens Flex (RP Flex) Extraction Tray
Version or Model: 20-009-024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NANOSPHERE, INC.

Primary DI Number: 00857573006263
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 164757242 *Terms of Use

Device Description: The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.

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:	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?
47922	Multiple-genus respiratory virus 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 virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZE	Influenza A And Influenza B Multiplex Nucleic Acid Assay
OEM	Human Metapneumovirus (Hmpv) Rna Assay System
OCC	Respiratory Virus Panel Nucleic Acid Assay System
OEP	Influenza A Virus Subtype Differentiation Nucleic Acid Assay
OZZ	Bordetella Pertussis Dna Assay System
OOU	Parainfluenza Multiplex Nucleic Acid Assay

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143653	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 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6cbdeee0-caf3-4aab-8124-743e1764f1bc
Public Version Date: December 18, 2023
Public Version Number: 7
DI Record Publish Date: September 23, 2016