DEVICE: ABBOTT PRISM (00380740008420)

Device Identifier (DI) Information

ABBOTT PRISM
6A36-11
In Commercial Distribution
06A3611
ABBOTT LABORATORIES
00380740008420
GS1

1
079226220 *Terms of Use
ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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
Chemiluminescent immunoassay analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
MZA TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK970042 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

3108bab4-9944-47dd-a054-1512e41f44a4
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)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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+1(877)422-2688
xx@xx.xx
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