AccessGUDID - DEVICE: Pregnenolone ELISA (B24211PRNHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Pregnenolone ELISA
Version or Model: 11-PRNHU-E01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-PRNHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24211PRNHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use.

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?
63758	Pregnenolone 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 pregnenolone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as an aid in the diagnosis of adrenal hyperplasia and hirsutism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JNG	Radioimmunoassay, Pregnenolone

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: 17332f19-e5ba-4e3f-bbae-1a16ab9b6c14
Public Version Date: June 02, 2023
Public Version Number: 1
DI Record Publish Date: May 25, 2023