AccessGUDID - DEVICE: ADVIA® Chemistry Hemoglobin A1c

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry Hemoglobin A1c_3 Calibrators
Version or Model: 10491408
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10491408
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414574516
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: HbA1C Kit - ADVIA Chem. - CAL - 2x4x0,5mL

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?
53315	Glycated haemoglobin (HbA1c) 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 measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081895	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: c9324205-edd9-4a71-982f-cfbec89f2cf6
Public Version Date: November 29, 2021
Public Version Number: 8
DI Record Publish Date: September 24, 2016