FDA.reportPublic FDA data

Reverse-Cyte 0.8% (A1, A2, B)

Primary DI
07640137340322
Brand
Reverse-Cyte 0.8% (A1, A2, B)
Company
Medion Grifols Diagnostics AG
Model
3x10 ml
Catalog number
213662
Device description
Reagent Red Blood Cells for confirmation of ABO Blood Grouping in gel technique. For in vitro diagnostic use.
Published
2016-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640137340322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640137340322076401373403227640137340322

GMDN Terms#

Term, Definition table
TermDefinition
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutinationA 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.

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
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
07640137341459Data-Cyte Plus 2 0.8%11x4 ml2136412024-04-22
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