DEVICE: EUROArrayProcessor reagent tray set (04049016148265)

Device Identifier (DI) Information

EUROArrayProcessor reagent tray set
ZM 9999-0640-5
In Commercial Distribution

EUROIMMUN Medizinische Labordiagnostika AG
04049016148265
GS1

1
322209263 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61298 General laboratory assay tray
A tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or automated liquid handling instruments or analysers. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NSU Instrumentation For Clinical Multiplex Test Systems
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4d1bce1e-6376-45b6-ad7e-60ca0f3bb80d
March 13, 2023
1
March 03, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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