AccessGUDID - DEVICE: LeucoScreen Plus Reagent 2 (05411967003044)

GUDID

Device Identifier (DI) Information

Brand Name: LeucoScreen Plus Reagent 2
Version or Model: LEUCOP2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fertipro NV

Primary DI Number: 05411967003044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373904101 *Terms of Use

Device Description: LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides useful information in semen samples where the concentration of round cells exceeds 1 million/ml. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic. The color of the substrate in peroxidase-positive white blood cells is bluish-grey to black instead of brown (LeucoScreen). For more information, visit the FertiPro website: www.fertipro.com

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:	No
Prescription Use (Rx):	No
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?
55966	Leukocyte myeloperoxidase (MPO) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the enzyme myeloperoxidase (MPO) in leukocytes from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LED	Stains, Chemical Solution

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 300 Microliter

Device Record Status

Public Device Record Key: e9d79254-265e-4236-8b4c-0489badb393b
Public Version Date: September 17, 2020
Public Version Number: 3
DI Record Publish Date: February 12, 2019