DEVICE: TintoMixing Station Kit (B502BSB74530)
Device Identifier (DI) Information
TintoMixing Station Kit
BSB-7453
In Commercial Distribution
BSB-7453
BIO SB, INC.
BSB-7453
In Commercial Distribution
BSB-7453
BIO SB, INC.
Accessory of the Tinto Stainer Plus Automated System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
66103 | Assay stirring set IVD |
A collection of containers (e.g., test tubes, cuvettes) and magnetic or non-magnetic stirring instruments (e.g., bars, balls) intended to be used to hold and facilitate the stirring/mixing of biological specimens, reagents, buffers, or other materials during in vitro diagnostic testing procedures (e.g., platelet aggregation study, clotting time assay) performed in the laboratory. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c8e7f86d-c759-4cd9-ad85-3ad5f7b14bcb
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 |
---|---|---|---|---|---|
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