FDA.reportPublic FDA data

Serodia TP-PA Kits

Primary DI
00869164000055
Brand
Serodia TP-PA Kits
Company
FUJIREBIO DIAGNOSTICS, INC.
Model
234952
Device description
100 test kit
Published
2023-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMTAntigens, Ha, Treponema Pallidum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMTAntigens, Ha, Treponema PallidumMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971502000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971502000SERODIA TP-PAScimedx Tekfile Services1997-11-13GMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869164000055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869164000055008691640000558691640000550869164000055

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
Handling Environment Temperature2 Degrees Celsius56 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-531-7963kits@fdi.com

Regulatory Flags#

DUNS number
079291908
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
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio CL00732024-11-04
00850212007041Beckman Coulter PK TP System Control SetPH35022016-09-16
00850212007058Beckman Coulter PK CMV-PA SYSTEM Control Set240226PA23022016-09-16
00869164000062Serodia TP-PA Kits2349762023-12-06
00869164000079Emit Cyclosporine Sample40080862023-12-06
00869164000000MESOMARK801-9052014-09-17
00869164000048Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator ToolCL00122022-11-10
00850212007096Lumipulse G Wash Solution40082482017-10-06
00869164000017Lumipulse G ROMACL00042016-09-19
00869164000024ROMA404-10US2016-09-19
00850212007072Fertility Control 21301622020-12-07
00850212007089Vitamin D Control21301662020-07-14
00850212007003FITC Anti-Rabies Monoclonal Globulin800-0922016-09-16
00850212007010Serodia TP-PA16262016-09-16
00850212007027Serodia TP-PA16332016-09-16
00850212007034Vitamin D Control21301522016-09-16
00850212007065Syphilis Control21301702017-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869164000062Serodia TP-PA KitsFUJIREBIO DIAGNOSTICS, INC.GMT2023-12-06
00850212007010Serodia TP-PAFUJIREBIO DIAGNOSTICS, INC.GMT2016-09-16
00850212007027Serodia TP-PAFUJIREBIO DIAGNOSTICS, INC.GMT2016-09-16