AccessGUDID - DEVICE: PCRopsis (B5502820250)

GUDID

Device Identifier (DI) Information

Brand Name: PCRopsis
Version or Model: Reagent Buccal
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 282025
Company Name: ENTOPSIS, LLC

Primary DI Number: B5502820250
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078294784 *Terms of Use

Device Description: PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for 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: cea6afc3-b675-4ef1-9f01-a288cd0cdc07
Public Version Date: April 12, 2024
Public Version Number: 2
DI Record Publish Date: April 19, 2021