AccessGUDID - DEVICE: Androstenedione (00404847453393)

GUDID

Device Identifier (DI) Information

Brand Name: Androstenedione
Version or Model: HYE-5339
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HYE-5339
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847453393
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:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum.

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: e101ada6-ea6f-4476-a8f6-3b35a711cb70
Public Version Date: November 21, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2021