DEVICE: ARCHITECT (00380740102746)

Device Identifier (DI) Information

ARCHITECT
4P52-20
In Commercial Distribution
04P5220
ABBOTT LABORATORIES
00380740102746
GS1

1
079226220 *Terms of Use
Hemoglobin A1c
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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
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.
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FDA Product Code

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Product Code Product Code Name
PDJ Hemoglobin A1c test system
LCP ASSAY, GLYCOSYLATED HEMOGLOBIN
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
JIT CALIBRATOR, SECONDARY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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
Handling Environment Humidity: exactly 0 Percent (%) Relative Humidity
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

02207528-d5f6-4823-a675-915045291c8c
March 29, 2018
2
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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