DEVICE: DRUGS OF ABUSE CAL (B80010029000010)

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Device Record History
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Device Identifier (DI) Information
DRUGS OF ABUSE CAL
DA+ CAL M LB
In Commercial Distribution

UTAK LABORATORIES, INC.
B80010029000010
HIBCC

1
092519016 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
30503 Multiple therapeutic drugs/drugs of abuse IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LAS Drug Specific Control Materials
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
39e000dd-95c6-4cab-a5c1-5453d44c9a17
May 04, 2022
1
April 26, 2022
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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
B80010029000011 4 B80010029000010 In Commercial Distribution Box
B80010029000012 5 B80010029000010 In Commercial Distribution Box
B80010029000013 10 B80010029000010 In Commercial Distribution Box
B80010029000016 25 B80010029000010 In Commercial Distribution Box
B80010029000017 50 B80010029000010 In Commercial Distribution Box
B80010029000018 100 B80010029000010 In Commercial Distribution 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

[?]
1-888-882-5522
welovecontrol@utak.com
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