FDA.reportPublic FDA data

SeroELISA Chlamydia IgA

Primary DI
07290001913161
Brand
SeroELISA Chlamydia IgA
Company
SAVYON DIAGNOSTICS LTD
Model
A113-01
Device description
The SeroELISAChlamydia IgA kit is intended for the determination of specific IgA antibodies to Chlamydia in a single human serum sample by an Enzyme-Linked Immunosorbent Assay (ELISA).For In Vitro Diagnostic Use.
Published
2025-05-29
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
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914327000SEROELISA(TM) CHLAMYDIA IGA TEST KITSavyon Diagnostics , Ltd.1992-06-09LJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290001913161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290001913161072900019131617290001913161

GMDN Terms#

Term, Definition table
TermDefinition
Chlamydia pneumoniae immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to Chlamydia pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533708202
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290006418326CHROMOSTREAKBD-915BD-9152026-05-27
07290006418111DIASLIDE URINE CULTURING DEVICEDS-1052026-05-04
07290013348531URISCREEN 101-012026-04-29
17290006558937Feminine Screening KitF-1-VO-CVS022026-02-22
07290006558930Feminine Screening KitF-1-VO-CVS022026-02-22
07290001913147SeroELISA Chlamydia IgGA111-01A111-012025-05-29
07290013348302Conjugate IgAFA233-12MFA233-12M2023-06-29
07290013348470Conjugate IgMFA232-12MFA232-12M2023-06-29
07290016332193Serum Diluent IgMFB262-03MFB262-03M2023-06-29
07290016332636Bordetella Pertussis IgGA2231-01MA2231-01M2023-06-16
07290013348487Bordetella immunology reagents IgA2233-012233-012023-06-29
07290013348494Bordetella immunology reagents IgM2232-012232-012023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290001913147SeroELISA Chlamydia IgGSAVYON DIAGNOSTICS LTDLJC2025-05-29
30014613200062QuickVueQUIDEL CORPORATIONLJC2018-11-10
05391516743952Trinity BiotechCLARK LABORATORIES, INC.LJC2017-05-07