AccessGUDID - DEVICE: UCP Home Drug Screening Test Strips (10817038021993)

GUDID

Device Identifier (DI) Information

Brand Name: UCP Home Drug Screening Test Strips
Version or Model: U-PCP-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U-PCP-101
Company Name: UCP BIOSCIENCES, INC.

Primary DI Number: 10817038021993
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 163610020 *Terms of Use

Device Description: UCP Home Drug Screening Test Strips Phencyclidine Test Strip

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
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?
30523	Phencyclidine (PCP) IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of phencyclidine (PCP) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCM	Enzyme Immunoassay, Phencyclidine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050540	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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8cdfe94b-9942-4066-b2db-6edb01112f59
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: January 31, 2019