DEVICE: ARCHITECT (00380740017415)

Device Identifier (DI) Information

ARCHITECT
8K26-25
In Commercial Distribution
08K2625
Abbott GmbH & Co. KG
00380740017415
GS1

1
315786293 *Terms of Use
ARCHITECT SHBG 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
Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of sex hormone binding globulin (SHBG) 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
JJX SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
JIT CALIBRATOR, SECONDARY
CDZ RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7baa7164-6a44-4af2-8d9d-266355a0e5ac
March 29, 2018
2
June 06, 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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