FDA.reportPublic FDA data

Data-Cyte Plus 2 0.8%

Primary DI
07640137341459
Brand
Data-Cyte Plus 2 0.8%
Company
Medion Grifols Diagnostics AG
Model
11x4 ml
Catalog number
213641
Device description
Reagent Red Blood Cells panel used for identification of unexpected antibodies in gel technique. For in vitro diagnotic use.
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640137341459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640137341459076401373414597640137341459

GMDN Terms#

Term, Definition table
TermDefinition
Antibody identification panel reagent red blood cell IVD, kit, agglutinationA collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483287020
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640137342272Data-Cyte Plus P 0.8%11x4ml2136882025-05-12
07640137341749Data-Cyte Plus 3% 11x4 ml2132312024-04-10
07640137341596Search-Cyte Pool 0.8%3x10 ml2132892024-04-09
07640137340285Data-Cyte Plus 0.8%11x4 ml2136542016-01-25
07640137340292Reverse-Cyte 3% (A1, B)2x10 ml2136352016-01-27
07640137340308Reverse-Cyte 3% (A1, A2, B)3x10 ml2136322016-01-27
07640137340315Reverse-Cyte 0.8% (A1, B)2x10 ml2136602016-01-27
07640137340322Reverse-Cyte 0.8% (A1, A2, B)3x10 ml2136622016-01-27
07640137340346Search-Cyte Plus 3%2x10 ml2136392016-01-27
07640137340353Search-Cyte TCS 3%3x10 ml2136312016-01-27
07640137340377Search-Cyte Plus 0.8%2x10 ml2136562016-01-27
07640137340384Search-Cyte TCS 0.8%3x10 ml2136552016-01-27
07640137340391Search-Cyte Pool 0.8%1x10 ml2136632016-01-27
07640137341442Data-Cyte Extend 0.8%4 x 4ml2136842024-04-22
07640137340278Data-Cyte Plus 3%11x4 ml2133922016-01-25
07640137340339Search-Cyte I+II 3%2x10 ml2136382016-01-27
07640137340360Search-Cyte I+II 0.8%2x10 ml2136572016-01-27
07640137340582BBQA II1 kit2136422016-09-26
07640137340599Coombs Control Cells1 x 10 ml2136302016-09-26
07640137340605DG Gel Extended Control4 x 6 ml2132852016-09-26