AccessGUDID - DEVICE: Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428 (00817302022292)

GUDID

Device Identifier (DI) Information

Brand Name: Carolina Liquid Chemistries Corp. Fentanyl Enzyme Immunoassay (FENT) DT428
Version or Model: DT428
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT428
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Fentanyl Enzyme Immunoassay

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?
63018	Fentanyl 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 fentanyl in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	Enzyme immunoassay, opiates

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2 R1 bottles and 2 R2 bottles
Total Volume: 30 Milliliter
Total Volume: 10 Milliliter

Device Record Status

Public Device Record Key: fc318dd7-acb8-4f31-a6ce-52f85514ac27
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 2020