DEVICE: ARCHITECT (00380740014896)

Device Identifier (DI) Information

ARCHITECT
7K77-10
In Commercial Distribution
07K7710
ABBOTT IRELAND
00380740014896
GS1

1
989964119 *Terms of Use
ARCHITECT Progesterone Controls
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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
Progesterone IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIT CALIBRATOR, SECONDARY
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
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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
Handling Environment Temperature: less than -18 Degrees Celsius
Special Storage Condition, Specify: Store at -10 degrees C or colder until first usage After each use immediately return the thawed calibrators to refrigerated storage (2 to 8 degrees C)
Storage Environment Temperature: less than -10 Degrees Celsius
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

989ffa74-a307-4dbc-9210-691724edc79a
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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