AccessGUDID - DEVICE: QUANTA Flash Calprotectin Extraction Buffer (08426950914693)

GUDID

Device Identifier (DI) Information

Brand Name: QUANTA Flash Calprotectin Extraction Buffer
Version or Model: 701354
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INOVA DIAGNOSTICS, INC.

Primary DI Number: 08426950914693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188354831 *Terms of Use

Device Description: 1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 125 mL, concentrated reagent.

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:	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?
62669	Clinical specimen extraction buffer IVD	A buffered solution intended to be used for the processing and preparation of a clinical specimen, for subsequent in vitro diagnostic testing, by extraction of specific target analytes present in the clinical specimen (e.g., proteins, antigens).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXO	Calprotectin, Fecal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170993	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 919f4e2d-24c9-48cf-a684-0dd3930663c0
Public Version Date: November 06, 2020
Public Version Number: 3
DI Record Publish Date: February 28, 2018