PK7400 TP HA CONTROLS

Primary DI: 05060515140047
Brand: PK7400 TP HA CONTROLS
Company: NEWMARKET BIOMEDICAL LIMITED
Model: B11187
Device description: PK7400 TP HA CONTROLS is intended for use with the PK7400 TP HA REAGENT (B11186) for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum, EDTA plasma and CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System.
Published: 2019-11-14
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Product Codes#

Code, Name table
Code	Name
GMR	Sera, Reactive And Non-Specific Control, Fta-Abs Test

Code, Device, Specialty table
Code	Device	Specialty	Class
GMR	Sera, Reactive And Non-Specific Control, Fta-Abs Test	Microbiology	2

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
05060515140047	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
05060515140047	05060515140047	5060515140047

Term, Definition table
Term	Definition
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen.

Type, Value, Unit table
Type	Value	Unit
Device Size Text, specify	0

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Method table
Method

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
05060515140030	PK7400 TP HA REAGENT	B11186		2019-11-14

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05391516747769	Trinity Biotech	MARDX DIAGNOSTICS, INC.	GMR	2016-09-19
05391516747776	Trinity Biotech	MARDX DIAGNOSTICS, INC.	GMR	2016-09-19