AccessGUDID - DEVICE: Quantisal (00840937112151)

GUDID

Device Identifier (DI) Information

Brand Name: Quantisal
Version or Model: QSI-0025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: QSI-0025
Company Name: IMMUNALYSIS CORPORATION

Primary DI Number: 00840937112151
Issuing Agency: GS1
Commercial Distribution End Date: September 06, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080589004 *Terms of Use

Device Description: Quantisal Oral Fluid Collection Device 25 pk

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?
61164	Oral/upper respiratory tract specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

FDA Premarket Submission

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

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05966e73-c1bd-4931-be61-ad8d2d9faced
Public Version Date: December 19, 2024
Public Version Number: 5
DI Record Publish Date: August 31, 2020