DEVICE: Panoscreen I and II (10888234000297)
Device Identifier (DI) Information
Panoscreen I and II
0002380
In Commercial Distribution
0002380
IMMUCOR, INC.
0002380
In Commercial Distribution
0002380
IMMUCOR, INC.
Panoscreen I and II is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual tube method. The configuration of this product is a 2-cell screen.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
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52544 | Antibody screening reagent red blood cell IVD, kit, agglutination |
A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
5108ef5b-5649-40b6-ac96-cb31ca1ae343
March 29, 2018
2
June 04, 2016
March 29, 2018
2
June 04, 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
[?]
1-855-466-8267
tech_support@immucor.com
tech_support@immucor.com