AccessGUDID - DEVICE: 5-HIAA ELISA (00404847418866)

GUDID

Device Identifier (DI) Information

Brand Name: 5-HIAA ELISA
Version or Model: EIA-1886
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-1886
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 00404847418866
Issuing Agency: GS1
Commercial Distribution End Date: June 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: Enzyme immunoassay for the in vitro diagnostic quantitative determination of 5-HIAA in human urine.

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?
65643	5-Hydroxyindoleacetic acid (5HIAA) 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 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen, using an enzyme immunoassay (EIA) method. 5HIAA is a serotonin metabolite associated with carcinoid tumours (e.g., of the enterochromaffin cells of the midgut).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDA	ACID, NITROUS AND NITROSONAPHTHOL, 5-HYDROXYINDOLE ACETIC ACID/SEROTONIN

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: 7dd3118d-2342-428c-826e-8c9013ca7f87
Public Version Date: July 26, 2023
Public Version Number: 2
DI Record Publish Date: July 28, 2021