DEVICE: Gamma Lewis Blood Group Substance (10888234000853)

Device Identifier (DI) Information

Gamma Lewis Blood Group Substance
0007702
In Commercial Distribution
0007702
IMMUCOR, INC.
10888234000853
GS1

1
061446282 *Terms of Use
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
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
Immunoglobulin removal reagent IVD A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin.
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FDA Product Code

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Product Code Product Code Name
KSX Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K802533 000
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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 1 and 10 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

3f8d156a-ffb8-468e-a8d9-c9155f68e5fb
July 06, 2018
3
April 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-855-466-8267
tech_support@immucor.com
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