FDA.reportPublic FDA data

Chlamydia Trachomatis IgG 120 Test Kit

Primary DI
00813545025519
Brand
Chlamydia Trachomatis IgG 120 Test Kit
Company
SCIMEDX CORPORATION
Model
I-CTR01G
Catalog number
I-CTR01G
Published
2016-09-20
Public version status
Update
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
LKIAntisera, Fluorescent, Chlamydia Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKIAntisera, Fluorescent, Chlamydia Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914953000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914953000IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYStellar Bio Systems, Inc.1992-02-19LKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545025519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545025519008135450255198135450255190813545025519

GMDN Terms#

Term, Definition table
TermDefinition
Chlamydia trachomatis immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Chlamydia trachomatis bacteria in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733101205MERIFLUOR ChlamydiaMERIDIAN BIOSCIENCE, INC.LKI2016-09-23
00813545025533Chlamydia Trachomatis 10wl 10 pkSCIMEDX CORPORATIONLKI2016-09-20
B110CH41120Chlamydia Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.LKI2016-09-12
B110CHG41200Chlamydia IgG ControlBion Enterprises, Ltd.LKI2016-09-12
B110CHM41300Chlamydia IgG ControlBion Enterprises, Ltd.LKI2016-09-12
B110CHN41100Chlamydia Negative ControlBion Enterprises, Ltd.LKI2016-09-12