AccessGUDID - DEVICE: Dade Fibrinogen Determination Reagents (00630414640105)

GUDID

Device Identifier (DI) Information

Brand Name: Dade Fibrinogen Determination Reagents
Version or Model: 10873937
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873937
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414640105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Quantitative determination of fibrinogen in human plasma

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?
55997	Fibrinogen assay (factor I) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFK	FIBRINOGEN DETERMINATION STANDARDS AND CONTROLS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 74e3a65e-c503-416a-a3fb-3b1a1a4a4e45
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024