FDA.reportPublic FDA data

OSOM Trich.10T Cntrl Kit

Primary DI
00742860100130
Brand
OSOM Trich.10T Cntrl Kit
Company
SEKISUI DIAGNOSTICS, LLC
Model
182
Catalog number
182
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JWZKIT, SCREENING, TRICHOMONAS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWZKit, Screening, TrichomonasMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033864000GENZYME OSOM TRICHOMONAS RAPID TESTGenzyme Corp.2004-04-02JWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742860100130PrimaryGS10
10742860100137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860100130007428601001307428601001300742860100130
1074286010013710742860100137

GMDN Terms#

Term, Definition table
TermDefinition
Trichomonas vaginalis antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from the parasitic protozoan Trichomonas vaginalis in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838011535REMELREMEL, INC.JWZ2023-01-04
00742860100123OSOM Trich V. 5 Test KitSEKISUI DIAGNOSTICS, LLCJWZ2016-09-20
00742860001819OSOM Trich V. 25 Test KitSEKISUI DIAGNOSTICS, LLCJWZ2016-09-16