hGH-ELISA

Basic Information

• Brand Name: hGH-ELISA
• Primary DI: 05400569000070
• Version / Model: KAP1081
• Company Name: Diasource Immunoassays S.A. SA
• Labeler DUNS: 458777323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-09
• Public Version: 1
• Public Version Date: 2020-01-17
• Public Version Status: New
• Public Device Record Key: d727c999-82d8-4c8b-a9ef-dea374621850

Device Description

hGH-ELISA

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CFL	RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE	Clinical Chemistry	862.1370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54219	Human growth hormone (HGH) 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 human growth hormone (HGH) 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	05400569000070	GS1