DEVICE: Gamma P1 Blood Group Substance (10888234000846)
Device Identifier (DI) Information
Gamma P1 Blood Group Substance
0007700
In Commercial Distribution
0007700
IMMUCOR, INC.
0007700
In Commercial Distribution
0007700
IMMUCOR, INC.
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
No | |
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No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
43805 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K802534 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 1 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9fa7d713-add6-4c04-8e5e-24423e67a08f
July 06, 2018
3
April 19, 2016
July 06, 2018
3
April 19, 2016
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
[?]
1-855-466-8267
tech_support@immucor.com
tech_support@immucor.com