DEVICE: DG Gel 8 Rh Pheno (08437014205237)

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Device Record History
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Device Identifier (DI) Information
DG Gel 8 Rh Pheno
210387
Not in Commercial Distribution
210387
DIAGNOSTIC GRIFOLS SA
08437014205237
GS1
April 15, 2025
1
463625602 *Terms of Use
The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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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?
52738 Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination
A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] of red blood cells, using an agglutination method.
Active false
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FDA Product Code

[?]
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
Handling Environment Temperature: between 2 and 25 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
cf147e4e-af84-4d2c-8914-56b2c63990b3
April 16, 2025
3
July 11, 2016
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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

[?]
(800)452-6877
service.americas@grifols.com
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