AccessGUDID - DEVICE: Androstenedione ELISA (04048474032659)

GUDID

Device Identifier (DI) Information

Brand Name: Androstenedione ELISA
Version or Model: EIA-3265
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-3265
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474032659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: The DRG Androstenedione ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum and EDTA plasma.

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?
54069	Androstenedione IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIZ	Radioimmunoassay, Androstenedione

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: d26cbb12-5638-457e-ac22-3ef8be4f4cfe
Public Version Date: September 06, 2023
Public Version Number: 1
DI Record Publish Date: August 29, 2023