Dimension® Flex® reagent cartridge TAC

Basic Information

• Brand Name: Dimension® Flex® reagent cartridge TAC
• Primary DI: 00842768035425
• Version / Model: 10700795
• Catalog Number: DF207
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: bce2321d-6c24-42bc-ae57-5d331a35fa8d

Device Description

Tacrolimus Flex® reagent cartridge, TAC, 80 tests (4 x 20)

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: 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
MLM	ENZYME IMMUNOASSAY, TRACROLIMUS	Clinical Chemistry	862.1678	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55442	Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug tacrolimus in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768035425	GS1
Unit of Use	00630414005980	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150168	000