AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251 (00817302023091)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251
Version or Model: DT251
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT251
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302023091
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CA (Calcium) 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?
45789	Calcium (Ca2+) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of calcium (Ca2+) in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CJY	AZO DYE, CALCIUM

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 at 8-30° C until expiration date
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert
Total Volume: 70 Milliliter

Device Record Status

Public Device Record Key: 4d1a4293-2f15-442d-9d40-98a6054cf883
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: October 17, 2016