DEVICE: P AMY (05055273200669)

Device Identifier (DI) Information

P AMY
AY7934
In Commercial Distribution
AY7934
RANDOX LABORATORIES LIMITED
05055273200669
GS1

1
227530649 *Terms of Use
The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Amylase 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 qualitative and/or quantitative detection of one or multiple amylase isoenzymes in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
JFJ Catalytic Methods, Amylase
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K971825 000
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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

dacb137c-0a9b-41bb-a35f-1d515a563971
July 06, 2018
3
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

[?]
+442894451070
technical.services@randox.com
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