AccessGUDID - DEVICE: Pointe Phencyclidine (PCP) Reagent Set (00811727016454)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Phencyclidine (PCP) Reagent Set
Version or Model: 60-PH0020-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-PH0020-100
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727016454
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Phencyclidine (PCP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

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?
55745	Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCM	Enzyme Immunoassay, Phencyclidine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020254	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: 960c0b3e-46a2-405b-a05a-1b5596a60fde
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020