AccessGUDID - DEVICE: iScreen™ (00817405024018)

GUDID

Device Identifier (DI) Information

Brand Name: iScreen™
Version or Model: ABTDOAW105402B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ABTDOAW105402B
Company Name: Instant Technologies, Inc.

Primary DI Number: 00817405024018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 019410187 *Terms of Use

Device Description: 5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50

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):	Yes
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
NFT	Test, Amphetamine, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter
NGG	Test, Methamphetamine, Over The Counter
NGL	Test, Opiates, Over The Counter
NFW	Test, Cannabinoid, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202567	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 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf7876aa-8b0e-446f-8920-0e798f08b786
Public Version Date: October 14, 2024
Public Version Number: 2
DI Record Publish Date: May 25, 2023