AccessGUDID - DEVICE: PCRopsis (B5507831000)

GUDID

Device Identifier (DI) Information

Brand Name: PCRopsis
Version or Model: Reagent RVD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 783100
Company Name: ENTOPSIS, LLC

Primary DI Number: B5507831000
Issuing Agency: HIBCC
Commercial Distribution End Date: February 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 078294784 *Terms of Use

Device Description: PCRopsis™ Reagent RVD with RVD Enhancer mediates extraction-free RT-qPCR of swab specimens transported in compatible universal transport medium.

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?
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6daf6e02-c093-4b0a-9dce-9f7e1fa99191
Public Version Date: May 06, 2022
Public Version Number: 4
DI Record Publish Date: September 08, 2020