AccessGUDID - DEVICE: cobas Factor II and Factor V Test (00875197005998)

GUDID

Device Identifier (DI) Information

Brand Name: cobas Factor II and Factor V Test
Version or Model: 07948352190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07948352190
Company Name: Roche Molecular Systems, Inc.

Primary DI Number: 00875197005998
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071674100 *Terms of Use

Device Description: No description.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
59586	Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).	Active	false
58952	Coagulation factor II (prothrombin) mutation IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the coagulation factor II (prothrombin) G20210A mutation associated with venous thrombosis, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPR	TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
NPQ	TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172913	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8becc8c-fb0b-40ea-99c8-af292e327364
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 14, 2018