CL AIA-PACK LH TEST CUP

Basic Information

• Brand Name: CL AIA-PACK LH TEST CUP
• Primary DI: 14562185399711
• Version / Model: N/A
• Company Name: TOSOH CORPORATION
• Labeler DUNS: 690571724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2025-09-01
• Public Version: 1
• Public Version Date: 2025-09-09
• Public Version Status: New
• Public Device Record Key: c6a63a15-e748-4d93-b508-220dba4e862f

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	862.1485	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54254	Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) 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
Package	24562185399718	GS1		40	In Commercial Distribution
Primary	14562185399711	GS1
Unit of Use	04562185399714	GS1

Customer Contacts

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

Storage Conditions

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