FITC TdT Reagent

Basic Information

• Brand Name: FITC TdT Reagent
• Primary DI: B7826100A00
• Version / Model: 6100A
• Catalog Number: 6100
• Company Name: Supertechs, Inc.
• Labeler DUNS: 071245690
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-08
• Public Version: 2
• Public Version Date: 2023-11-15
• Public Version Status: Update
• Public Device Record Key: ff382136-36a8-4854-b353-ae6a0cc7eefd

Device Description

Analyte Specific Reagent FITC conjugated mouse anti-human TdT 4 clone mix (2 IgG1 & 2 IgG2a) 0.5 mL vial for approximately 50 tests

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54700	Terminal deoxynucleotidyl transferase (TdT) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of terminal deoxynucleotidyl transferase (TdT) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B7826100A00	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to light
• Type: Storage Environment Temperature
• Temperature Range: – -20 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius