DEVICE: ARCHITECT (00380740054151)

Device Identifier (DI) Information

ARCHITECT
6K99-40
In Commercial Distribution
06K9940
ABBOTT LABORATORIES
00380740054151
GS1

1
079226220 *Terms of Use
Quantia Alpha 1-Antitrypsin
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Device Characteristics

Labeling does not contain MRI Safety Information
No
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
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.
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FDA Product Code

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Product Code Product Code Name
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
DEM ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050596 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
Handling Environment Temperature: less than 29 Degrees Celsius
Special Storage Condition, Specify: Do not freeze.
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Handling 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

095c0b9d-fda2-4588-bec0-39a8a58167c5
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(877)422-2688
xx@xx.xx
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