AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616 (00817302023060)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® HDLD REAGENT PRODUCT NO. DT616
Version or Model: DT616
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT616
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302023060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: HDLD (HDL Cholesterol Direct) w/ calibrator 4 x 250 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?
53391	High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBS	LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE-OXIDASE, HDL
LBR	LDL & VLDL PRECIPITATION, HDL

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
Total Volume: 63 Milliliter
Total Volume: 12 Milliliter
Device Size Text, specify: Kit contains 4 R1 bottles, 4 R2 bottles, calibrator, 1 reagent package insert and 1 calibrator package insert

Device Record Status

Public Device Record Key: 4341145c-c8e3-46fd-adc6-4c374396c1be
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: October 17, 2016