DEVICE: TintoAutomation Cleaner (B502BSB70630)
Device Identifier (DI) Information
TintoAutomation Cleaner
BSB 7063
In Commercial Distribution
BSB 7063
BIO SB, INC.
BSB 7063
In Commercial Distribution
BSB 7063
BIO SB, INC.
The TintoAutomation Cleaner is a 3-component cleaning solution for removal of DAB chromogen stains and precipitates from the TintoStainer Plus automated platform, glassware, labware, or other surfaces that come in contact with DAB.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No | |
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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? |
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59058 | Wash/cleaning solution IVD, automated/semi-automated system |
A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f96dd3d7-4907-4c33-940c-54f15752d313
March 26, 2025
1
March 18, 2025
March 26, 2025
1
March 18, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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(800)561-1145
sales@biosb.com
sales@biosb.com