AccessGUDID - DEVICE: Procleix WNV/Babesia Quality Control (00850032683043)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00850032683043
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?
61304	PCR/NAT negative control IVD	A material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).	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: 1785ab82-7c80-4219-b6c3-e7cf3c4a4e15
Public Version Date: August 15, 2023
Public Version Number: 2
DI Record Publish Date: February 15, 2023