DEVICE: ThromboType® (10888234500285)
Device Identifier (DI) Information
ThromboType®
THROMBOTYPE
Not in Commercial Distribution
THROMBOTYPE
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution
THROMBOTYPE
IMMUCOR GTI DIAGNOSTICS, INC.
ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
56569 | Multiple human platelet antigen (HPA) typing IVD, kit, multiplex |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple human platelet antigen (HPA) systems which may include HPA-1, HPA-2, HPA-3, HPA-4, HPA-5 and/or HPA-15 in a clinical specimen, using a multiplex method.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MYP | Test,Platelet Antibody |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK050040 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c6ce24bf-c08c-44b8-8f34-2e0ebf4b23f1
August 15, 2018
5
July 08, 2016
August 15, 2018
5
July 08, 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 |
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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
[?]
855-466-8267
waukeshatechsupport@immucor.com
waukeshatechsupport@immucor.com