AccessGUDID - DEVICE: Dehydroepiandrosterone (DHEA) ELISA (B24211HEAHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Dehydroepiandrosterone (DHEA) ELISA
Version or Model: 11-HEAHU-E01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11-HEAHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24211HEAHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The Dehydroepiandrosterone ELISA is intended for the direct quantitative determination of DHEA by enzyme immunoassay in human 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?
54137	Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone (DHEA) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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: 7a32a161-fa01-4b5f-83eb-ca3a170dec33
Public Version Date: September 19, 2022
Public Version Number: 1
DI Record Publish Date: September 09, 2022