AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201 (00817302020014)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP. ® HCY RGT. KIT BL-201
Version or Model: BL201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL201
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: HCY (Homocysteine) w/ cal 1X 100 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?
53747	Homocysteine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPS	URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM
JIT	CALIBRATOR, SECONDARY

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: HCY is stable for 30 days
Special Storage Condition, Specify: HCY Calibrators are stable to 60 days when stored at 2 to 8°C
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 4 Milliliter
Total Volume: 3 Milliliter
Device Size Text, specify: Kit contains 1 R1, 1 R2, CAL 0.0µmol/L & CAL 28µmol/L and 1 package insert
Total Volume: 25 Milliliter

Device Record Status

Public Device Record Key: 00018988-a376-4fbc-a212-a8d4bd2e5387
Public Version Date: August 14, 2023
Public Version Number: 4
DI Record Publish Date: September 01, 2016