AccessGUDID - DEVICE: DCA™ Systems Hemoglobin A1c Reagent Kit (00630414532806)

GUDID

Device Identifier (DI) Information

Brand Name: DCA™ Systems Hemoglobin A1c Reagent Kit
Version or Model: 10311134
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5035C
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414532806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: DCA HbA1c Test Kit (monitoring only) - INTL.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
53313	Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen using a liquid chromatography method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	ASSAY, GLYCOSYLATED HEMOGLOBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951361	000

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d1725da-5f65-44a3-b911-6630f316095a
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016