AccessGUDID - DEVICE: Carolina Liquid Chemistries CRPhsWR (00817302022414)

GUDID

Device Identifier (DI) Information

Brand Name: Carolina Liquid Chemistries CRPhsWR
Version or Model: BL-645B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BL-645B
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302022414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CRPhsWR (C-Reactive Protein)

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?
53707	C-reactive protein (CRP) IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DCK	C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

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

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 13 Milliliter
Device Size Text, specify: Kit contains 2 R1 bottles and 2 R2 bottles

Device Record Status

Public Device Record Key: e5ecf7c9-073b-4313-9067-01861999327e
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: March 08, 2019