Active-B12 (Holotranscobalamin) ELISA

Basic Information

• Brand Name: Active-B12 (Holotranscobalamin) ELISA
• Primary DI: 04049325008304
• Version / Model: AX53101
• Catalog Number: AX53101
• Company Name: IBL International GmbH
• Labeler DUNS: 312694785
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-03-27
• Public Version Status: Update
• Public Device Record Key: ce419d2b-ebc3-4db8-9cfd-77f08037ceaf
• Distribution End Date: 2024-04-29

Device Description

Active-B12 (Holotranscobalamin) ELISA - 96 determinations

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
CDD	Radioassay, Vitamin B12	Clinical Chemistry	862.1810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54458	Vitamin B12 IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of vitamin B12, also known as cobalamin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049325008304	GS1

Customer Contacts

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

Storage Conditions

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