DEVICE: ALP (05055273200331)

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Device Identifier (DI) Information

ALP
AP313
AP313
RANDOX LABORATORIES LIMITED
05055273200331
GS1
1
An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
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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
Alkaline phosphatase (ALP) isoenzyme IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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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
Special Storage Condition, Specify: Stable for 1 week at +2 to +8°C or 1 day at +15 to +25°C once R1a and R1b reconstituted
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
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)

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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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