AccessGUDID - DEVICE: ONLINE DAT Phencyclidine Plus (07613336121450)

GUDID

Device Identifier (DI) Information

Brand Name: ONLINE DAT Phencyclidine Plus
Version or Model: 08058130190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08058130190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336121450
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?
55749	Phencyclidine (PCP) 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 qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCM	Enzyme immunoassay, phencyclidine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043305	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: 80d07e62-acd7-419d-9d9f-398c6d004e19
Public Version Date: March 16, 2020
Public Version Number: 1
DI Record Publish Date: March 06, 2020