AccessGUDID - DEVICE: Factor V Leiden (00842768033520)

GUDID

Device Identifier (DI) Information

Brand Name: Factor V Leiden
Version or Model: 10459420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OQYI11
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768033520
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Russell Viper Venom-based test for screening of resistance to Activated Protein C (APC) in plasma from individuals with the Factor V (Leiden) defect

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?
56221	Activated protein C resistance ratio (APCR) IVD, kit, clotting	A collection of reagents and other associated materials intended to be used to determine the activated protein C resistance ratio (APCR) of a clinical specimen, using a clotting method to measure clotting time with and without added activated protein C.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGW	TEST, TIME, PARTIAL THROMBOPLASTIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992456	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: b477d26f-22e1-4d7f-8bc9-295231c6be72
Public Version Date: February 20, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016