AccessGUDID - DEVICE: Berichrom Protein C (00630414639710)

GUDID

Device Identifier (DI) Information

Brand Name: Berichrom Protein C
Version or Model: 10873893
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873893
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414639710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies

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?
47388	Protein C IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative measurement of protein C in a clinical specimen, using a chromogenic method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGP	TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890634	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: f39eb219-7090-4203-b919-0f9d6942fdfc
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024