DEVICE: ARCHITECT (00380740001339)

Device Identifier (DI) Information

ARCHITECT
1L76-01
In Commercial Distribution
01L7601
ABBOTT LABORATORIES
00380740001339
GS1

1
079226220 *Terms of Use
ARCHITECT Sirolimus Calibrators
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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
Rapamycin (sirolimus) 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 the immunosuppressant drug rapamycin (sirolimus) in a clinical specimen.
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FDA Product Code

[?]
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

[?]
Storage and Handling
Handling Environment Temperature: less than 0 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

c1a58cec-80bc-4b27-85d2-54cce1cc8cae
July 06, 2018
3
June 06, 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

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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(877)422-2688
xx@xx.xx
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