DEVICE: MLB 2 (07611969950911)

Device Identifier (DI) Information

MLB 2
805205100
In Commercial Distribution
805205100
Bio-Rad Medical Diagnostics GmbH
07611969950911
GS1

1
312576506 *Terms of Use
Modified LISS-Enhancement media for TANGO® optimo and tube test; 10x10ml
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Low ionic strength saline (LISS) immunohaematology reagent IVD A substance or reactant that is a low ionic strength saline (LISS) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells.
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FDA Product Code

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Product Code Product Code Name
KSZ System, Test, Automated Blood Grouping And Antibody
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

386d3f0d-a3c6-4083-807f-1674f065285f
March 29, 2018
2
July 01, 2015
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-224-6723
techsupport.bmd@bio-rad.com
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