AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424 (00817302020861)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424
Version or Model: DT424
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT424
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: BUP (Buprenorphine) 2 x 500 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:	Yes
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?
42751	Buprenorphine 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 buprenorphine in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DJG	ENZYME IMMUNOASSAY, OPIATES
LAS	DRUG SPECIFIC CONTROL MATERIALS
DLJ	CALIBRATORS, DRUG SPECIFIC

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 on board a clinical analyzer for 28 days when stored at 2 to 8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Kit can be expected to perform satisfactorily until the expiration date if stored in the refrigerator at 2-8°C.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 46.5 Milliliter
Device Size Text, specify: Kit contains 2 R1 and 2 R2 bottles and 1 package insert

Device Record Status

Public Device Record Key: 3867cd56-8324-4e7f-b13a-26dcd6dc9785
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016