AIA-PACK ACTH Control Set

Basic Information

• Brand Name: AIA-PACK ACTH Control Set
• Primary DI: 04560189212558
• Version / Model: N/A
• Company Name: TOSOH CORPORATION
• Labeler DUNS: 690571724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2024-02-15
• Public Version Status: Update
• Public Device Record Key: 95b5ef9c-3d40-4317-bdd0-eb66891fed44

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59440	Familial glucocorticoid deficiency (FGD) IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict familial glucocorticoid deficiency (FGD), an inborn genetic disorder associated with adrenal unresponsiveness to the adrenocorticotropic hormone (ACTH) and hypopituitarism due to mutations in the gene encoding melanocortin-2 receptor (MC2R).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560189212558	GS1

Customer Contacts

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

Storage Conditions

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