TGF Beta-1 ELISA

Basic Information

• Brand Name: TGF Beta-1 ELISA
• Primary DI: B24220TGF1HUE010
• Version / Model: 20-TGF1HU-E01
• Catalog Number: 20-TGF1HU-E01
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Labeler DUNS: 784143778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 1
• Public Version Date: 2020-07-27
• Public Version Status: New
• Public Device Record Key: d949d1e6-7f81-4326-8ca3-9b3116b5368e

Device Description

The TGF Beta-1 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF Beta-1 in serum and cell culture supernatant. For in vitro diagnostic use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
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	B24220TGF1HUE010	HIBCC

Customer Contacts

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

Storage Conditions

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