DEVICE: ARCHITECT (00380740000301)

Device Identifier (DI) Information

ARCHITECT
1E11-20
In Commercial Distribution
01E1120
ABBOTT LABORATORIES
00380740000301
GS1

1
079226220 *Terms of Use
Gentamicin
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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
Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin 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
LCD ENZYME IMMUNOASSAY, GENTAMICIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K060709 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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 reagents or expose reagents to temperatures above 32 degrees celcius.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ca0382e5-e6af-4e49-aad5-8271938f703f
July 06, 2018
3
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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