AccessGUDID - DEVICE: TGF-Beta 2 ELISA (00404847423969)

GUDID

Device Identifier (DI) Information

Brand Name: TGF-Beta 2 ELISA
Version or Model: EIA-2396
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-2396
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847423969
Issuing Agency: GS1
Commercial Distribution End Date: November 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65493	Transforming growth factor beta protein 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 transforming growth factor beta (TGF-beta) protein in a clinical specimen, using an enzyme immunoassay (EIA) method. TGF-beta-1 and TGF-beta-2 are cytokines involved in various biological processes and are associated with developmental, neurological, and immune system disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFL	RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d23414a-1719-467b-a3d3-fbf4858d86b3
Public Version Date: November 21, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2021