Search-Cyte Plus 0.8% 213656

GUDID 07640137340377

Reagent Red Blood Cells for use in the detection of unexpected antibodies. For in vitro diagnostic use.

Medion Grifols Diagnostics AG

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Primary Device ID07640137340377
NIH Device Record Key18dc45ed-c7ae-465a-9609-446212260588
Commercial Distribution StatusIn Commercial Distribution
Brand NameSearch-Cyte Plus 0.8%
Version Model Number2x10 ml
Catalog Number213656
Company DUNS483287020
Company NameMedion Grifols Diagnostics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640137340377 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-01-27

Devices Manufactured by Medion Grifols Diagnostics AG

07640137341442 - Data-Cyte Extend 0.8%2024-04-30 Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. Data-Cyte Extend 0.8% cannot de
07640137341459 - Data-Cyte Plus 2 0.8%2024-04-30 Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
07640137341749 - Data-Cyte Plus 3% 2024-04-18 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
07640137341596 - Search-Cyte Pool 0.8%2024-04-17 Reagent Red Blood Cells for use in the detection of unexpected antibodies in gel technique. For in vitro diagnostic use
07640137341381 - DG Gel Essential Control2019-05-01 DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures fo
07640137340278 - Data-Cyte Plus 3%2018-03-29 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnostic use.
07640137340285 - Data-Cyte Plus 0.8%2018-03-29 Reagent Red Blood Cells panel used for identification of unexpected antibodies. For in vitro diagnotic use.
07640137340292 - Reverse-Cyte 3% (A1, B)2018-03-29 Reagent Red Blood Cells for confirmation of ABO Blood Grouping. For in vitro diagnostic use.

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