AccessGUDID - DEVICE: Ansh Labs Activin A ELISA (00853592008059)

GUDID

Device Identifier (DI) Information

Brand Name: Ansh Labs Activin A ELISA
Version or Model: AL-110-i
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL-110-i
Company Name: Ansh Labs, LLC

Primary DI Number: 00853592008059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057752914 *Terms of Use

Device Description: The Activin A enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of Activin A in human serum and other biological fluids. This assay is intended 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?
65861	Activin A 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 the hormone activin A in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of some types of cancer (e.g., colorectal and breast cancer).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: cc590a38-63db-46ad-91da-d072471f47c6
Public Version Date: August 20, 2024
Public Version Number: 1
DI Record Publish Date: August 12, 2024