AccessGUDID - DEVICE: alpha 1-Acid Glycoprotein (08058056680648)

GUDID

Device Identifier (DI) Information

Brand Name: alpha 1-Acid Glycoprotein
Version or Model: A26838
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A26838
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680648
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The kit is intended for the quantitative determination of Alpha 1-Acid Glycoprotein (AGP) in serum and plasma by immunoturbidimetry. 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:	No
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?
53607	Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alpha-1-acid glycoprotein (orosomucoid) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKL	Alpha-1-Acid-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
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 88 Milliliter

Device Record Status

Public Device Record Key: cccbfe42-8328-4d2f-bdcc-9d63a37eeec7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 15, 2017