AccessGUDID - DEVICE: ADVIA® Chemistry IGM

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry IGM_2 Reagents
Version or Model: 10309032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2193483
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414513126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: IgM - ADVIA Chem. - RGT - 4x90 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):	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?
53793	Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CFN	METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992662	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
Special Storage Condition, Specify: Do not freeze
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: c961d10a-e4de-4af7-a77b-408ed5ef9a64
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016