DEVICE: ARCHITECT (00380740001353)

Device Identifier (DI) Information

ARCHITECT
1L76-55
In Commercial Distribution
01L7655
ABBOTT LABORATORIES
00380740001353
GS1

1
079226220 *Terms of Use
ARCHITECT Sirolimus Whole Blood Precipitation Reagent
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug rapamycin (sirolimus) in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIT CALIBRATOR, SECONDARY
NRP Sirolimus test system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070822 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

69276a56-b9d6-4817-98b1-e203ef5516cd
July 06, 2018
3
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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