DEVICE: INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test (10796918002034)

Device Identifier (DI) Information

INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test
03-4437-50
In Commercial Distribution

ALFA SCIENTIFIC DESIGNS, INC.
10796918002034
GS1

50
176391167 *Terms of Use
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BZD COC MOR300 THC XTC
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

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Product Code Product Code Name
DKE Reagents, Test, Tetrahydrocannabinol
DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
DJC Thin Layer Chromatography, Methamphetamine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
JXM Enzyme Immunoassay, Benzodiazepine
DKZ Enzyme Immunoassay, Amphetamine
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FDA Premarket Submission

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a9bef977-97c7-463f-8e33-54ab091f330e
June 10, 2022
3
May 01, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00796918002037 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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