AccessGUDID - DEVICE: Procleix WNV/Babesia Quality Control (00850032683050)

GUDID

Device Identifier (DI) Information

Brand Name: Procleix WNV/Babesia Quality Control
Version or Model: Babesia Positive Control
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Primary DI Number: 00850032683050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056570085 *Terms of Use

Device Description: Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.

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?
64381	Multiple Babesia species nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the Babesia protozoa (e.g., B. microti, B. duncani, B. divergens and B. venatorum) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTM	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK220746	0

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f123b2f2-bd36-494e-8c8d-e65ddb66b6bb
Public Version Date: August 15, 2023
Public Version Number: 2
DI Record Publish Date: February 15, 2023