DEVICE: Referencells A1 and B (10888234000273)

Device Identifier (DI) Information

Referencells A1 and B
0002345
In Commercial Distribution
0002345
IMMUCOR, INC.
10888234000273
GS1

1
061446282 *Terms of Use
This configuration of the product contains two (2) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
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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?
52691 Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination
A collection of specifically characterized reagent red blood cells that are supplied together and intended to be used in reverse ABO blood group testing of a clinical specimen using an agglutination method. Cells are selected due to their individual blood group specificities, which may include blood group antigens A1, A2, B, AB and/or O.
Active false
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

7a22a504-c409-4403-864f-76025c018d40
March 29, 2018
2
September 24, 2014
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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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