AccessGUDID - DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300 (00817302020076)

GUDID

Device Identifier (DI) Information

Brand Name: CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300
Version or Model: AU-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AU-300
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: HbA1c (Hemoglobin A1c Direct) 1 x 200 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?
53316	Glycated haemoglobin (HbA1c) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

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 on board a clinical analyzer for 30 days when stored at 2 to 8°C
Special Storage Condition, Specify: Unopened reagents are stable to expiration date with stored at 2 to 8°C

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter
Total Volume: 10 Milliliter
Total Volume: 15 Milliliter
Device Size Text, specify: Kit contains 1 R1, 1 R2, 1 R1B, 2 Lysis Buffer (B1), and 1 package insert
Total Volume: 23 Milliliter

Device Record Status

Public Device Record Key: 22d2c68d-8419-4bd6-8919-b1b9197287b5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016