AccessGUDID - DEVICE: N Supplementary Reagent/Precipitation (00842768011443)

GUDID

Device Identifier (DI) Information

Brand Name: N Supplementary Reagent/Precipitation
Version or Model: 10446458
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OUMU15
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768011443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Supplementary reagent for multiple protein assays on Siemens systems

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?
42651	Buffered isotonic saline reagent IVD	A buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	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 [?]
K860894	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: 60ee582d-d920-4e2b-a9e1-5651d0b5b9c6
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016