ACTH [Adrenocorticotropic Hormone] ELISA

Basic Information

• Brand Name: ACTH [Adrenocorticotropic Hormone] ELISA
• Primary DI: 00083059070231
• Version / Model: 7023
• Company Name: BIOMERICA, INC.
• Labeler DUNS: 067647321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 1
• Public Version Date: 2020-07-09
• Public Version Status: New
• Public Device Record Key: c9289fd8-3b06-45cc-a3f9-3038e810ad98

Device Description

The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.

Device Characteristics

• Single Use: No
• 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: 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
CKG	Radioimmunoassay, Acth	Clinical Chemistry	862.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54056	Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) 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	00083059070231	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982608	000