ANTI-TLE1

Basic Information

• Brand Name: ANTI-TLE1
• Primary DI: 00810119671486
• Version / Model: AMB58-5M
• Catalog Number: AMB58-5M
• Company Name: BIOGENEX LABORATORIES
• Labeler DUNS: 042697045
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-03
• Public Version: 1
• Public Version Date: 2023-04-11
• Public Version Status: New
• Public Device Record Key: fbbe445e-26fc-433c-82bd-8bf4737180ec

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: 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63907	Transducin-like enhancer protein IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of a transducin-like enhancer (TLE) protein [e.g., TLE1] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810119671486	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	6	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 2-8°C