DEVICE: ARCHITECT (00380740138738)

Device Identifier (DI) Information

ARCHITECT
6P30-21
In Commercial Distribution
06P3021
ABBOTT LABORATORIES
00380740138738
GS1

1
079226220 *Terms of Use
ARCHITECT ROMA
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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
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.
Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human epididymis protein 4 (HE4) ovarian cancer marker in a clinical specimen, using a chemiluminescent immunoassay method.
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FDA Product Code

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Product Code Product Code Name
ONX ovarian adnexal mass assessment score test system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151502 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

378924fb-677e-4f84-a777-75fc49d17b3e
July 06, 2018
3
September 09, 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

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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(877)422-2688
xx@xx.xx
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