AccessGUDID - DEVICE: Free Estriol ELISA (04048474016123)

GUDID

Device Identifier (DI) Information

Brand Name: Free Estriol ELISA
Version or Model: EIA-1612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-1612
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474016123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: The DRG Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy.

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?
61973	Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGI	RADIOIMMUNOASSAY, ESTRIOL

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: c3d36688-8497-4b3b-bce2-42dc2ed8f0cb
Public Version Date: December 02, 2024
Public Version Number: 1
DI Record Publish Date: November 22, 2024