AccessGUDID - DEVICE: Cfas DAT Qualitative Plus Clinical (04015630997800)

GUDID

Device Identifier (DI) Information

Brand Name: Cfas DAT Qualitative Plus Clinical
Version or Model: 4590856190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4590856190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 04015630997800
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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:	Yes
Prescription Use (Rx):	Yes
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?
55460	Multiple drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIF	DRUG MIXTURE CONTROL MATERIALS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090939	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: 74319ebf-9ccb-44f7-8bde-6609b1fc9a74
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016