DEVICE: BD MAX™ System Refurb (00382904419271)
Device Identifier (DI) Information
BD MAX™ System Refurb
441927
In Commercial Distribution
441927
BECTON, DICKINSON AND COMPANY
441927
In Commercial Distribution
441927
BECTON, DICKINSON AND COMPANY
Instrument Max Clinical Refurb
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
48031 | Thermal cycler nucleic acid amplification analyser IVD, laboratory |
An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OOI | real time Nucleic acid amplification system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 18 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Height: 72.4 Centimeter |
Width: 94 Centimeter |
Depth: 75.4 Centimeter |
Device Record Status
70411075-aa77-4090-9bd8-81961bfa8429
March 08, 2024
6
May 19, 2016
March 08, 2024
6
May 19, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com