DEVICE: BD ProbeTec™ ET Instrument, U.S. (00382904404789)

Device Identifier (DI) Information

BD ProbeTec™ ET Instrument, U.S.
440478
In Commercial Distribution
440478
BECTON, DICKINSON AND COMPANY
00382904404789
GS1

1
122561087 *Terms of Use
BD ProbeTec™ ET Instrument, U.S.
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Fluorescent immunoassay analyser IVD, laboratory, automated A stationary 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 in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), 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

[?]
Product Code Product Code Name
LSL DNA-REAGENTS, NEISSERIA
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984631 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 18 and 33 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Width: 28.5 Inch
Height: 21.5 Inch
Depth: 28.5 Inch
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Device Record Status

ebc4636b-a731-4bc8-8a69-c1de70997267
July 06, 2018
3
May 19, 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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No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
Technical_services@bd.com
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