AccessGUDID - DEVICE: Alere iCup Dx Pro 2 (00858945006836)

GUDID

Device Identifier (DI) Information

Brand Name: Alere iCup Dx Pro 2
Version or Model: I-DXP-177-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: I-DXP-177-01
Company Name: Instant Technologies, Inc.

Primary DI Number: 00858945006836
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019410187 *Terms of Use

Device Description: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP/BZO/BUP/COC/OPI300/OXY/THC)

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:	Yes
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
LDJ	Enzyme Immunoassay, Cannabinoids
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJG	Enzyme Immunoassay, Opiates
JXM	Enzyme Immunoassay, Benzodiazepine
DKZ	Enzyme Immunoassay, Amphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133968	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: 7e37f6ce-ca68-49ea-9d12-f91c1583979a
Public Version Date: October 14, 2024
Public Version Number: 10
DI Record Publish Date: October 26, 2016