DEVICE: IH-Cell A2 (07611969952250)

Device Identifier (DI) Information

IH-Cell A2
814020100
In Commercial Distribution
814020100
Bio-Rad Medical Diagnostics GmbH
07611969952250
GS1

1
312576506 *Terms of Use
Reagent Red Blood Cells; 0.6 ± 0.1 %; Pooled cells for reverse grouping with IH-Cards; 1 x 10 mL
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
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
Group A2 Rh (D) negative reagent red blood cell IVD, antigen A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A2 Rh(D) negative. These reagent cells are positive for blood group antigen A [ABO001] but negative for blood group antigens A1 [ABO004] and Rh(D) [RH001].
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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
No CLOSE

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 2 and 8 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

cea95f28-cc4f-4ee5-9b5e-7dee57107bf0
March 29, 2018
2
January 20, 2017
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-224-6723
techsupport.bmd@bio-rad.com
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