DEVICE: ProScreen (00858998006777)

Device Identifier (DI) Information

ProScreen
PSD-5AB
Not in Commercial Distribution
PSD-5AB
Instant Tech Subsidiary Acquisition
00858998006777
GS1
June 01, 2018
1
080317182 *Terms of Use
Drugs of Abuse Test Card, AMP/BZO/COC/OPI2000/THC
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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

[?]
Product Code Product Code Name
JXM Enzyme Immunoassay, Benzodiazepine
LDJ Enzyme Immunoassay, Cannabinoids
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DKZ Enzyme Immunoassay, Amphetamine
DJG Enzyme Immunoassay, Opiates
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K113046 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

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

d41bc012-b1fb-4e03-94d4-ff76249c5a82
June 10, 2022
6
September 19, 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
No Package DIs found
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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

[?]
1-888-669-4337
xxx@xx.xx
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