AccessGUDID - DEVICE: ProScreen (00858998006319)

GUDID

Device Identifier (DI) Information

Brand Name: ProScreen
Version or Model: PSDA-5MB300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PSDA-5MB300
Company Name: Instant Tech Subsidiary Acquisition

Primary DI Number: 00858998006319
Issuing Agency: GS1
Commercial Distribution End Date: January 29, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 080317182 *Terms of Use

Device Description: Drugs of Abuse Test Card, BZO/COC/MET1000/OPI300/THC with Cr, Ni, pH, Bl, S.G.

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:	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?
46994	Multiple drugs of abuse 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 multiple drugs of abuse 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
JXM	Enzyme Immunoassay, Benzodiazepine
LDJ	Enzyme Immunoassay, Cannabinoids
DJG	Enzyme Immunoassay, Opiates
DJC	Thin Layer Chromatography, Methamphetamine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113046	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 36 and 86 Degrees Fahrenheit
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: 6c429536-ab86-4abb-82a1-48f303c1b7b0
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 19, 2016