DEVICE: Drew Scientific (00817274020517)
Device Identifier (DI) Information
Drew Scientific
DSJ-9001-001
In Commercial Distribution
DREW SCIENTIFIC, INC.
DSJ-9001-001
In Commercial Distribution
DREW SCIENTIFIC, INC.
DS360 HbA1c Analyzer with accessories
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
56724 | Multichannel immunoassay analyser IVD |
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCP | Assay, Glycosylated Hemoglobin |
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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No Device Sizes |
Device Record Status
c795068e-8cc3-4c9a-96e1-e14526350093
August 03, 2023
4
September 09, 2016
August 03, 2023
4
September 09, 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 |
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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
[?]
1-305-324-2300
customerservice@erbadiagnostics.com
customerservice@erbadiagnostics.com