DEVICE: QuikScreen (00748349000113)

Device Identifier (DI) Information

QuikScreen
60510
In Commercial Distribution

SYNTRON BIORESEARCH, INC.
00748349000113
GS1

1
174517060 *Terms of Use
QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50
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Device Characteristics

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

GMDN

[?]

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?
55463 Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly 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

[?]
Product Code Product Code Name
LFH U.V. Spectrometry, Tricyclic Antidepressant Drugs
DJG Enzyme Immunoassay, Opiates
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 [?]
K071489 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

18039c7b-cb32-48a5-b4e7-08c12a230e3f
July 06, 2023
5
October 04, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20748349000117 4 10748349000110 In Commercial Distribution Shipper Box
10748349000110 25 00748349000113 In Commercial Distribution Kit Box
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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