AccessGUDID - DEVICE: a-Amylase EPS Pancreatic (07613336121016)

GUDID

Device Identifier (DI) Information

Brand Name: a-Amylase EPS Pancreatic
Version or Model: 08056820190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08056820190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336121016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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:	No
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?
59073	Amylase isoenzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an amylase isoenzyme in a clinical specimen, using a spectrophotometry method. This test is typically used to detect salivary or pancreatic alpha-amylase to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFJ	CATALYTIC METHODS, AMYLASE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972250	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
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: c1df94c3-d4fe-473b-b46f-97760d3d85e4
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: March 05, 2020