SpermMar IgG Negative Control

Basic Information

• Brand Name: SpermMar IgG Negative Control
• Primary DI: 05411967001361
• Version / Model: SPMG_N
• Company Name: Fertipro NV
• Labeler DUNS: 373904101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-22
• Public Version: 4
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: c7b0d307-b57b-4936-838e-ab3f9eb0c58a

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTO	Reagent, Immunoassay, Igg	Immunology	866.5530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42222	Sperm antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05411967001361	GS1
Package	05411967003174	GS1		1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	2.5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius