AccessGUDID - DEVICE: Ansh Labs Dried Blood Spot (DBS) AMH ELISA (00853592008134)

GUDID

Device Identifier (DI) Information

Brand Name: Ansh Labs Dried Blood Spot (DBS) AMH ELISA
Version or Model: AL-129-i
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL-129-i
Company Name: Ansh Labs, LLC

Primary DI Number: 00853592008134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057752914 *Terms of Use

Device Description: The Anti-Müllerian hormone (DBS AMH) enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of AMH in human dried blood spot. This kit is intended for in-vitro diagnostic use only.

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):	No
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?
58413	Anti-Mullerian hormone (AMH) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of anti-Mullerian hormone (AMH) in a clinical specimen, using an enzyme immunoassay (EIA) method.	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: 103d218a-d7c5-46c3-a033-da7a0a8d0637
Public Version Date: June 10, 2021
Public Version Number: 1
DI Record Publish Date: June 02, 2021