TGF-B2 ELISA

Basic Information

• Brand Name: TGF-B2 ELISA
• Primary DI: 00840239023964
• Version / Model: EIA-2396
• Catalog Number: EIA-2396
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-23
• Public Version: 1
• Public Version Date: 2023-08-31
• Public Version Status: New
• Public Device Record Key: 2d0e2dec-2007-4cc6-a4c2-ffc9b6b2ded1

Device Description

The DRG TGF-ß2 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF-ß2 in serum, plasma and cell culture supernatant.

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: Yes
• 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
65494	Trypanosoma brucei total antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to the parasitic protozoan Trypanosoma brucei in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to detect infection with Trypanosoma brucei, the parasite associated with African trypanosomiasis (sleeping sickness). It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239023964	GS1

Customer Contacts

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

Storage Conditions

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