DEVICE: iScreen™ (00817405023943)

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Device Record History
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Device Identifier (DI) Information
iScreen™
ABTOFCUBE0401A
In Commercial Distribution
ABTOFCUBE0401A
Instant Technologies, Inc.
00817405023943
GS1

25
019410187 *Terms of Use
4 Panel E&I Oral Click Cube AMP50, COC20, MET50, OPI40
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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. 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
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt
PVH Test, Opiates, Employment And Insurance Testing, Exempt
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
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
25027a5a-88da-4fc3-abc0-8f295b18843f
May 09, 2023
1
May 01, 2023
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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
30817405023944 4 00817405023943 In Commercial Distribution Master Carton
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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: 10817405023940 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-340-4029
Qa.Portsmouth@abbott.com
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