SpermMar IgG Negative Control

GUDID 05411967001361

SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website: www.fertipro.com

Fertipro NV

Sperm antibody IVD, control
Primary Device ID05411967001361
NIH Device Record Keyc7b0d307-b57b-4936-838e-ab3f9eb0c58a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpermMar IgG Negative Control
Version Model NumberSPMG_N
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
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
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com

Device Dimensions

Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter
Total Volume2.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105411967001361 [Primary]
GS105411967003174 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Product Code

KTOReagent, Immunoassay, Igg

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-11
Device Publish Date2018-08-22

On-Brand Devices [SpermMar IgG Negative Control]

54119670013614SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm
05411967001361SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm

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