FDA.reportPublic FDA data

DG Gel Essential Control

Primary DI
07640137341381
Brand
DG Gel Essential Control
Company
Medion Grifols Diagnostics AG
Model
2x2x6ml
Catalog number
213288
Device description
DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for: (i) the determination of the ABO, Rh and K antigens; (ii) the determination of the appropriate ABO blood group antibodies; and (iii) the detection of unexpected antibodies.For use with DG Gel 8 technique.For in vitro diagnostic use.
Published
2019-04-23
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
07640137341381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640137341381076401373413817640137341381

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunohaematology test IVD, controlA collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.

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
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