SpermMar IgG Negative Control

GUDID 54119670013614

SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be fo

Fertipro NV

Sperm antibody IVD, control Sperm antibody IVD, control
Primary Device ID54119670013614
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

Operating and Storage Conditions

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
GS154119670013614 [Primary]

FDA Product Code

KTOReagent, Immunoassay, Igg

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.