AccessGUDID - DEVICE: Procleix Babesia Assay (00859882007740)

GUDID

Device Identifier (DI) Information

Brand Name: Procleix Babesia Assay
Version or Model: Calibrators
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Primary DI Number: 00859882007740
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056570085 *Terms of Use

Device Description: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

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?
52138	Babesia microti nucleic acid IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Babesia microti in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2927c0b7-0499-4acd-98db-5a4b07627eb6
Public Version Date: March 28, 2019
Public Version Number: 1
DI Record Publish Date: March 20, 2019