LeucoScreen Plus Reagent 2

GUDID 05411967003044

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

Fertipro NV

Leukocyte myeloperoxidase (MPO) IVD, reagent
Primary Device ID05411967003044
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
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com

Device Dimensions

Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter
Total Volume300 Microliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
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
GS105411967003044 [Primary]

FDA Product Code

LEDStains, Chemical Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-10
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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