AccessGUDID - DEVICE: Fetuin-A ELISA (B24243FETHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Fetuin-A ELISA
Version or Model: 43-FETHU-E01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 43-FETHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24243FETHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date: December 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human Fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum, plasma (EDTA or Heparin), cell culture supernatant, tissue extracts and urine. The measurement of Fetuin-A in serum or plasma aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein. This Fetuin-A ELISA kit is 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?
58915	Alpha-2-HS-glycoprotein (AHSG)/fetuin-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 alpha-2-HS-glycoprotein (AHSG), also referred to as fetuin-A, in a clinical specimen using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEF	Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

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: 8cc2b1c6-ab4e-48b7-8a81-1ed0ddf6cd8a
Public Version Date: December 10, 2020
Public Version Number: 2
DI Record Publish Date: September 25, 2020