AccessGUDID - DEVICE: HairCheck-DT (PCP) (00868586000254)

GUDID

Device Identifier (DI) Information

Brand Name: HairCheck-DT (PCP)
Version or Model: K042726
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Quest Diagnostics

Primary DI Number: 00868586000254
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 189222334 *Terms of Use

Device Description: HairCheck-DT (PCP) is an ELISA test kit used for qualitative detection of phencyclidine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

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 [?]
Premarket Submission Number Not Available/Not Released

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: d3934d59-3a54-4822-b5e8-938584c56e35
Public Version Date: March 24, 2022
Public Version Number: 4
DI Record Publish Date: September 23, 2016