AccessGUDID - DEVICE: Androstenedione ELISA (B24211ANRHUE010)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B24211ANRHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The Androstenedione ELISA is for the direct quantitative determination of androstenedione in human serum by an enzyme immunoassay. 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?
54069	Androstenedione IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIZ	Radioimmunoassay, Androstenedione

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: 4585fc5a-e4a7-4c4a-990f-f3622ab31ead
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020