Gamma Lewis Blood Group Substance

Primary DI: 10888234000853
Brand: Gamma Lewis Blood Group Substance
Company: IMMUCOR, INC.
Model: 0007702
Catalog number: 0007702
Device description: Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
Published: 2016-04-19
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Contact Domains#

Code, Name table
Code	Name
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Code, Device, Specialty table
Code	Device	Specialty	Class
KSX	Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use	Hematology	2

Submission, Supplement table
Submission	Supplement
K802533	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K802533	000	GAMMA LEWIS BLOOD GROUP SUBSTANCE	Gamma Biologicals, Inc.	1980-11-12	KSX

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
10888234000853	Primary	GS1	0

Source identifier, GTIN-14 normalized table
Source identifier	GTIN-14 normalized
10888234000853	10888234000853

Term, Definition table
Term	Definition
Immunoglobulin removal reagent IVD	A substance or reactant intended to be used alone or in combination with other IVDs for the removal, adsorption, absorption, or inactivation of non-specific immunoglobulins and/or rheumatoid factor antibodies present in a clinical specimen, to prevent interference when testing for other specific classes of immunoglobulin.

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	1 Degrees Celsius	10 Degrees Celsius

Method table
Method

Phone, Email table
Phone	Email
1-855-466-8267	tech_support@immucor.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
10888234002291	Capture LISS	0066908	0066908	2022-09-03
10888234001027	H.P.C. (Human Platelet Concentrate)	0057320	0057320	2016-04-18
10888234002475	ImmuLINK	0030311		2024-12-05
10888234000495	Red Blood Cell (RBC) Storage Solution	0005036	0005036	2016-04-15
10888234001065	Specimen Diluent	0066052	0066052	2016-04-18
10888234001072	Specimen Diluent	0066053	0066053	2016-04-18
10888234001041	Galileo Neo	0064599	0064599	2016-04-18
10888234001584	Galileo Echo	0087000	0087000	2016-04-18
10888234001591	CMT Plates	0089000	0089000	2016-04-18
10888234002321	NEO Iris	0064597	0064597	2018-12-10
10888234002338	Echo Lumena	0086998	0086998	2018-06-01
10888234001546	Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum	0066902	0066902	2022-09-03
10888234001553	Capture-R Select	0066903	0066903	2022-09-03
10888234001560	Capture-P	0066904	0066904	2022-09-03
10888234001577	Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum	0066905	0066905	2022-09-03
10888234002307	Capture-R Ready Indicator Red Cells	0066907	0066907	2022-09-03
10888234002314	Capture-P Indicator Red Cells	0066906	0066906	2022-09-03
10888234001522	Referencells	0066900	0066900	2022-08-03
10888234001539	Capture-R Ready-Screen 3	0066901	0066901	2022-08-01
10888234002239	Gamma-Clone Anti-Fya (Monoclonal) Blood Grouping Reagent	10 mL size vial / 5mL fill volume	0066430	2022-04-22

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00630414287201	Atellica HEMA Calibrator	Siemens Healthcare Diagnostics Inc.	KSX	2026-02-06
10888234000846	Gamma P1 Blood Group Substance	IMMUCOR, INC.	KSX	2016-04-19