LeucoScreen Plus Reagent 2

GUDID 54119670030444

LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. The kit provides

Fertipro NV

Leukocyte myeloperoxidase (MPO) stain IVD, kit Leukocyte myeloperoxidase (MPO) stain IVD, kit
Primary Device ID54119670030444
NIH Device Record Keye9d79254-265e-4236-8b4c-0489badb393b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeucoScreen Plus Reagent 2
Version Model NumberLEUCOP2
Company DUNS373904101
Company NameFertipro NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS154119670030444 [Primary]

FDA Product Code

LEDStains, Chemical Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-12

On-Brand Devices [LeucoScreen Plus Reagent 2]

54119670030444LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidas
05411967003044LeucoScreen Plus™ is an improved histochemical staining kit for the determination of peroxidas

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