DEVICE: THEO (05055273206432)

Device Identifier (DI) Information

THEO
TD3412
Not in Commercial Distribution
TD3412
RANDOX LABORATORIES LIMITED
05055273206432
GS1
September 24, 2016
1
227530649 *Terms of Use
For the quantitative in vitro determination of Theophylline in human serum
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the anti-asthma drug theophylline in a clinical specimen, using and enzyme immunoassay (EIA) method.
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FDA Product Code

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Product Code Product Code Name
KLS Enzyme Immunoassay, Theophylline
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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
Special Storage Condition, Specify: Do not freeze
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

bf1b5e5a-9b27-4056-bdc7-9fcecbe29182
March 29, 2018
2
September 24, 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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+442894451070
technical.services@randox.com
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