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: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
BK180280	0

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
BK180280	0

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
07640137341381	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
07640137341381	07640137341381	7640137341381

Term, Definition table
Term	Definition
Multiple immunohaematology test IVD, control	A 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.

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
07640137342272	Data-Cyte Plus P 0.8%	11x4ml	213688	2025-05-12
07640137341749	Data-Cyte Plus 3%	11x4 ml	213231	2024-04-10
07640137341596	Search-Cyte Pool 0.8%	3x10 ml	213289	2024-04-09
07640137340285	Data-Cyte Plus 0.8%	11x4 ml	213654	2016-01-25
07640137340292	Reverse-Cyte 3% (A1, B)	2x10 ml	213635	2016-01-27
07640137340308	Reverse-Cyte 3% (A1, A2, B)	3x10 ml	213632	2016-01-27
07640137340315	Reverse-Cyte 0.8% (A1, B)	2x10 ml	213660	2016-01-27
07640137340322	Reverse-Cyte 0.8% (A1, A2, B)	3x10 ml	213662	2016-01-27
07640137340346	Search-Cyte Plus 3%	2x10 ml	213639	2016-01-27
07640137340353	Search-Cyte TCS 3%	3x10 ml	213631	2016-01-27
07640137340377	Search-Cyte Plus 0.8%	2x10 ml	213656	2016-01-27
07640137340384	Search-Cyte TCS 0.8%	3x10 ml	213655	2016-01-27
07640137340391	Search-Cyte Pool 0.8%	1x10 ml	213663	2016-01-27
07640137341442	Data-Cyte Extend 0.8%	4 x 4ml	213684	2024-04-22
07640137341459	Data-Cyte Plus 2 0.8%	11x4 ml	213641	2024-04-22
07640137340278	Data-Cyte Plus 3%	11x4 ml	213392	2016-01-25
07640137340339	Search-Cyte I+II 3%	2x10 ml	213638	2016-01-27
07640137340360	Search-Cyte I+II 0.8%	2x10 ml	213657	2016-01-27
07640137340582	BBQA II	1 kit	213642	2016-09-26
07640137340599	Coombs Control Cells	1 x 10 ml	213630	2016-09-26