0 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12

Basic Information

• Brand Name: 0 Calibrator Matrix for FSH, Ferritin, Folate & Vit B12
• Primary DI: 00816870023502
• Version / Model: 731MM
• Catalog Number: 731MM
• Company Name: MONOBIND, INC.
• Labeler DUNS: 083155515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-13
• Public Version: 1
• Public Version Date: 2024-09-23
• Public Version Status: New
• Public Device Record Key: 140ba8f2-a8f5-4958-a911-c43d79aafabf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
GIF	DILUENT, BLOOD CELL	Hematology	864.8200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816870023502	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch

Storage Conditions

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