AccessGUDID - DEVICE: Dade® Thrombin Reagent (00842768003943)

GUDID

Device Identifier (DI) Information

Brand Name: Dade® Thrombin Reagent
Version or Model: 10445720
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B4233-25
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768003943
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies

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?
56000	Fibrinogen assay (factor I) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQJ	SYSTEM, FIBRINOGEN DETERMINATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050928	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: 7baf9ba8-ae5e-4826-9b45-e68435a5a8cc
Public Version Date: February 21, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016