FDA.reportPublic FDA data

PK7400 TP HA REAGENT

Primary DI
05060515140030
Brand
PK7400 TP HA REAGENT
Company
NEWMARKET BIOMEDICAL LIMITED
Model
B11186
Device description
PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
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
CodeName
MYRTest, Donor, Syphilis, Antigens, Treponemal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYRTest, Donor, Syphilis, Antigens, TreponemalMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060515140030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060515140030050605151400305060515140030

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutinationA collection of reagents and other associated materials 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, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
217095816
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
05060515140047PK7400 TP HA CONTROLSB111872019-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336183083Elecsys SyphilisRoche Diagnostics GmbHMYR2023-10-05
07613336228463Elecsys SyphilisRoche Diagnostics GmbHMYR2023-10-05
10888234001485TPHA ScreenIMMUCOR, INC.MYR2016-04-15
10888234001492TPHA Screen DiluentIMMUCOR, INC.MYR2016-04-15
10888234001508TPHA Screen Positive Control and TPHA Screen Negative ControlIMMUCOR, INC.MYR2016-04-15