DEVICE: Bromelin for Erytype (07611969951307)

Device Identifier (DI) Information

Bromelin for Erytype
806210100
In Commercial Distribution
806210100
Bio-Rad Medical Diagnostics GmbH
07611969951307
GS1

1
312576506 *Terms of Use
Red Blood Cell Diluent for TANGO instruments, 10x10 ml
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Bromelin immunohaematology reagent IVD A substance or reactant that is a bromelin enzyme solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by enzymatically digesting red cell membrane proteins and removing sialic acid residues.
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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 [?]
BK040070 0
No CLOSE

Sterilization

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

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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

ab4467f3-d462-49b5-bf27-e7ec21eed877
July 06, 2018
3
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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