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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100376Acucy Flu Test Kit10102019-08-20
00742860100383Acucy Influenza A&B Control Kit10112019-08-23
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
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30
00628063401116MicroalbuminSK252-20SK252-202019-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00742860100062OSOM BV Blue Control KitSekisui Diagnostics, LLCJTR2025-12-29
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