DEVICE: MLB 2 (07611969965731)

Device Identifier (DI) Information

MLB 2
805200100
In Commercial Distribution
805200100
Bio-Rad Medical Diagnostics GmbH
07611969965731
GS1

1
312576506 *Terms of Use
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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 salt solution (LISS) immunohaematology reagent IVD A substance or reactant known as low ionic-strength salt solution (LISS), or low ionic strength saline, 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. It is a solution typically consisting of a sodium salt, glycine and low-salt albumin.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KSZ System, Test, Automated Blood Grouping And Antibody
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK040070 0
BK080012 0
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6b5befb5-7fa1-4513-8859-022a9d201426
September 12, 2018
4
December 26, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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