AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227 (00817302022964)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227
Version or Model: DT227
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT227
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022964
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: AMY (Amylase) 4 X 300 tests

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?
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 [?]
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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Reagent is stable when stored at 2-8° C until expiration date

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 4 Bottles of reagent and 1 package insert
Total Volume: 55 Milliliter

Device Record Status

Public Device Record Key: ee858cf0-5c16-4296-a97f-dccaf47379f0
Public Version Date: July 06, 2023
Public Version Number: 4
DI Record Publish Date: October 17, 2016