AccessGUDID - DEVICE: INSTANT-VIEW MDMA (XTC) Urine Dip-Strip Test (10796918000238)

GUDID

Device Identifier (DI) Information

Brand Name: INSTANT-VIEW MDMA (XTC) Urine Dip-Strip Test
Version or Model: 03-2957
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALFA SCIENTIFIC DESIGNS, INC.

Primary DI Number: 10796918000238
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 176391167 *Terms of Use

Device Description: INSTANT-VIEW MDMA (XTC) Urine Dip-Strip Test

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):	No
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?
55489	Amphetamine/methamphetamine group 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 belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] 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
DJC	Thin Layer Chromatography, Methamphetamine

[?]

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Sterilization

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

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

[?]

DEVICE: INSTANT-VIEW MDMA (XTC) Urine Dip-Strip Test (10796918000238)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact