FDA.reportPublic FDA data

Pathfinder

Primary DI
00847865012775
Brand
Pathfinder
Company
Bio-RAD Laboratories, Inc.
Model
12000149
Catalog number
12000149
Device description
Pathfinder Chlamydia trachomatis 2 Well Direct Specimen Control Slides
Published
2023-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LJPANTISERUM, FLUORESCENT, CHLAMYDIA TRACHOMATIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJPAntiserum, Fluorescent, Chlamydia TrachomatisMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880031000PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATISKallestad Diag, A Div. of Erbamont, Inc.1988-03-17LJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865012775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865012775008478650127758478650127750847865012775

GMDN Terms#

Term, Definition table
TermDefinition
Chlamydia trachomatis antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from Chlamydia trachomatis bacteria in a clinical specimen.

Device Sizes#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384503032IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDEOXOID LIMITEDLJP2024-07-03
05032384502943IMAGEN ChlamydiaOXOID LIMITEDLJP2024-06-19
G5229030001Chlamydia trachomatis / C. trach IgG IFA 96 TestHemagen Diagnostics, Inc.LJP2023-10-05
G5229030011Chlamydia trachomatis / C. trach IgG IFA Slide Only KitHemagen Diagnostics, Inc.LJP2023-10-05
00847865001410PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001427PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001434PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001441PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
05056080501901PathoDx Chlamydia trachomatis Control SlideREMEL EUROPE LIMITEDLJP2021-07-21
05056080501918PathoDx Chlamydia Culture ConfirmationREMEL EUROPE LIMITEDLJP2021-07-21
05056080501925PathoDx Chlamydia trachomatis Direct SpecimenREMEL EUROPE LIMITEDLJP2021-07-21
30014613330547D3DIAGNOSTIC HYBRIDS, INC.LJP2018-08-30
30014613330554D3DIAGNOSTIC HYBRIDS, INC.LJP2018-07-22