AccessGUDID - DEVICE: Pancreatic Amylase (08058056680587)

GUDID

Device Identifier (DI) Information

Brand Name: Pancreatic Amylase
Version or Model: A53704
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A53704
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056680587
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Pancreatic Amylase assay is an in vitro diagnostic test used for the determination on AU480, AU680 and AU5800 automatic analyzers of the pancreatic amylase in serum and plasma by enzymatic colorimetric method. The assay is intended for professional 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?
52943	Amylase isoenzyme 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 qualitative and/or quantitative detection of one or multiple amylase isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFJ	Catalytic Methods, Amylase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051447	000

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
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 102 Milliliter

Device Record Status

Public Device Record Key: aa2db97d-78c3-4073-b329-5978e36c83af
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 29, 2016