FDA.reportPublic FDA data

OSOM BVBlue Transport Swabs

Primary DI
00742860100680
Brand
OSOM BVBlue Transport Swabs
Company
SEKISUI DIAGNOSTICS, LLC
Model
186
Device description
OSOM BVBlue Transport Swab Set
Published
2026-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JTRKit, Quality Control For Culture Media

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTRKit, Quality Control For Culture MediaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50742860100685PackageGS124In Commercial Distribution
00742860100680PrimaryGS10
10742860100687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074286010068550742860100685
00742860100680007428601006807428601006800742860100680
1074286010068710742860100687

GMDN Terms#

Term, Definition table
TermDefinition
Sexually transmitted infection (STI) testing specimen collection kit IVD, clinicalA collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.

Regulatory Flags#

DUNS number
966812344
Device count
30
Premarket exempt
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
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
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845357000047KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000078KWIK-STIK™ PlusMICROBIOLOGICS INC.JTR2020-04-30
10845357000146KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000177KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000207KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000238KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000269KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000290KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000320KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000351KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000412KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000474KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000504KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000535KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000566KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000597KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000689KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000719KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000740KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000771KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000801KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000832KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000863KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000924KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000955KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357000986KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001075KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001105KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001136KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30
10845357001167KWIK-STIK™MICROBIOLOGICS INC.JTR2020-04-30