Monobind AccuLite sTfR CLIA Kit - 96 Wells

Basic Information

• Brand Name: Monobind AccuLite sTfR CLIA Kit - 96 Wells
• Primary DI: 00816870020358
• Version / Model: 8675-300
• Catalog Number: 8675-300A
• Company Name: MONOBIND, INC.
• Labeler DUNS: 083155515
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-11
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: fc6fb958-6178-4f26-90a7-4269ffb4d0de

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: 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
DDG	TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53992	Transferrin/transferrin isoform IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of transferrin or a transferrin isoform(s) [e.g., beta-2-transferrin, carbohydrate deficient transferrin] in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816870020358	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	7.75	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Handling Environment Temperature
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius