DEVICE: ARCHITECT (00380740101220)

Device Identifier (DI) Information

ARCHITECT
5P04-01
In Commercial Distribution
05P0401
ABBOTT LABORATORIES
00380740101220
GS1

1
079226220 *Terms of Use
TDM Multiconstituent Calibrator
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple-therapy therapeutic drug monitoring IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Handling Environment Temperature: less than 29 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Opened calibrator is stable for 60 days at 2 to 8 degrees Celsius or for 24 hours at 15 to 30 degrees Celsius if kept tightly capped.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b883f275-620c-4a64-bbdd-b6c4c3ecbf17
March 29, 2018
2
June 06, 2016
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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: 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(877)422-2688
xx@xx.xx
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