DEVICE: ARCHITECT (00380740117115)

Device Identifier (DI) Information

ARCHITECT
8D06-31
In Commercial Distribution
08D0631
Abbott GmbH & Co. KG
00380740117115
GS1

1
315786293 *Terms of Use
ARCHITECT Syphilis TP Reagent Kit
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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
Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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FDA Product Code

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Product Code Product Code Name
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
LIP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
JIT CALIBRATOR, SECONDARY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153730 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 2 and 8 Degrees Celsius
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

85708933-8c8b-4de4-8b46-9c595ab17c99
July 06, 2018
3
September 09, 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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