Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells

Basic Information

• Brand Name: Monobind AccuLite CA 15-3 CLIA Kit - 96 Wells
• Primary DI: 00816870022178
• Version / Model: 5675-300
• Catalog Number: 5675-560A
• 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: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 3b53e1c3-00fc-4cff-aeef-460c1eed70ae

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
MOI	SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60975	Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, 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	00816870022178	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