AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET (00817302020175)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET
Version or Model: ST500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST500
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: Vitamin D-direct w/ cal 1 x 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?
54474	Multiple form 25-hydroxy Vitamin D IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.	Active	false
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRG	SYSTEM, TEST, VITAMIN D
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

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: Reagents, calibrators, diluent and control are stable when stored at 2 to 8°C until the expiration date on the label. After use, the solutions should be kept capped in its reagent bottle.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter
Device Size Text, specify: Kit contains 1 R1, 1 R2, 1 R3, 1 R4 (diluent), 1 each calibrators, C1, C2, C3, C4,& C5 and 1 package insert.
Total Volume: 7.5 Milliliter
Total Volume: 17 Milliliter
Total Volume: 13 Milliliter

Device Record Status

Public Device Record Key: b275ccd1-7630-410a-b749-f0a9a773cff9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016