AccessGUDID - DEVICE: Human Chorionic Gonadotropin (hCG) ELISA (00840239017833)

GUDID

Device Identifier (DI) Information

Brand Name: Human Chorionic Gonadotropin (hCG) ELISA
Version or Model: EIA-1783
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-1783
Company Name: DRG International Inc

Primary DI Number: 00840239017833
Issuing Agency: GS1
Commercial Distribution End Date: July 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
42658	Human chorionic gonadotropin beta-core fragment 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 human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHI	Visual, pregnancy hCG, prescription use

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 13 Milliliter
Total Volume: 18 Milliliter
Device Size Text, specify: Conjugate Reagent
Device Size Text, specify: Stop Solution
Total Volume: 11 Milliliter
Device Size Text, specify: Zero Buffer
Device Size Text, specify: Standards
Total Volume: 1 Milliliter
Device Size Text, specify: TMB

Device Record Status

Public Device Record Key: 915ac122-b410-438a-8310-7020b7c065be
Public Version Date: July 26, 2023
Public Version Number: 4
DI Record Publish Date: March 20, 2019