510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: K052007 B. Purpose for Submission: The submission is for clearance of the ABX Pentra 400 Clinical Chemistry Analyzer and ABX Pentra Glucose reagents and Optional I.S.E. Module for Sodium, Potassium. ABX Pentra XL80 Hematology Analyzer 26 Parameters. Compatible with ABX Pentra ML. And User Safety. View and Download Horiba ABX Micros ES60 user manual online. ABX Micros ES60 Laboratory Equipment pdf manual download.
Pentra 400 Manual
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DESCRIPTION
The ABX Pentra 400 is an extremely compact Clinical Chemistry benchtop analyzer. Its automation and continuous loading provides enhanced productivity in a user-friendly environment.
FORUMSView All (3)
Ask a New QuestionPentra C400 User Manual
2Replies10 months ago | 10 months agoTroubleshooting the pentra I am looking for insight on this analyzer! Does anyone use a third party field service co. In California?Reply |
| -Tathiane Schiabel Scicchitano a year ago | a year agoControles trabalho com o equipamento referido porem nao sei passar os controles podem me auxiliarem quanto aos comando no equipamento? ja passo as amostras porem se acabar os controles nao sei como procederReply |
0Replies4 years ago | 4 years agoProblem with Gluk and ALB not passing I run the controls for P and N control and the ALB and Gluk are coming out high. What can I check to fix this problem? I have a Horiba ABX Pentra 400 Reply |
DOCUMENTS / MANUALSView All
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FEATURES
- A number of tests per cassette based on monthly consumption
- Extended linearity and increased stability
- Just one calibrator and two controls for your routine analyses
- All the calibrators of the specific proteins are liquid
- Less post-dilution due to greater linearity
- Based on the latest research in Clinical Chemistry and complies with international recommendations (IFCC)
- Standardized and in compliance with international recommendations
- All specific proteins are standardized against CRM 470
- Purified and concentrated antiserums
- Long shelf-life (up to 5 years)
- 55 on-board assays
- Innovative cassette format
- Integrated work station and validation station
- Touch screen
- Real-time viewing of workflow
SPECIFICATIONS
| Height | 25 in |
| Length | 28 in |
| Weight | 264 lbs |
| Width | 40 in |
User Manual Pdf Download
Additional Specifications
Horiba Abx Pentra 400 User Manual
Sample Dilution: 1/2 to 1/22,500
Sample Type: Serum, plasma, urine, CSF, whole Blood, homogeneous fluids
Throughput: 420 Tests/Hr