FDA.reportPublic FDA data

Acucy Calibration Device

Primary DI
00742860100345
Brand
Acucy Calibration Device
Company
Sekisui Diagnostics, LLC
Model
1031
Published
2019-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PSZDevices Detecting Influenza A, B, And C Virus Antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742860100345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742860100345007428601003457428601003450742860100345

GMDN Terms#

Term, Definition table
TermDefinition
Optical laboratory instrument performance standard calibrator/control IVD, reusableA solid phase or liquid reference standard of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.

Regulatory Flags#

DUNS number
966812344
Device count
1
DM exempt
false
Premarket exempt
false
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
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00695684744250AimStep Flu A&B Test KitGERMAINE LABORATORIES, INCPSZ2026-05-11
06970640093097INNOVITAInnovita (Tangshan) Biological Technology Co., Ltd.PSZ2026-04-15
00742860100413Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
10742860100410Acucy Printer PaperSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100444Acucy Reader A/C AdapterSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00742860100475Acucy System Universal DrawerSEKISUI DIAGNOSTICS, LLCPSZ2026-02-27
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
20885380200844CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
50885380200845CARDINAL HEALTHCardinal Health 200, LLCPSZ2024-08-02
00850056728706ViraDx™ SARS-CoV-2/Flu A+B Rapid Antigen TestLumos Diagnostics, Inc.PSZ2023-11-30
00848838027031Remel REMEL, INC.PSZ2021-11-12
30848838027032Remel REMEL, INC.PSZ2021-11-12
03848838027038Remel REMEL, INC.PSZ2021-11-12
00742860100390OSOM ULTRA PLUS FLU A&B TestSekisui Diagnostics, LLCPSZ2020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control KitSekisui Diagnostics, LLCPSZ2020-06-01
10742860100397OSOM ULTRA PLUS FLU A&B Test SEKISUI DIAGNOSTICS, LLCPSZ2020-06-01
00742860100338Acucy SystemSEKISUI DIAGNOSTICS, LLCPSZ2019-09-24
00742860100383Acucy Influenza A&B Control KitSekisui Diagnostics, LLCPSZ2019-08-23
00742860100376Acucy Flu Test KitSekisui Diagnostics, LLCPSZ2019-08-20
10811877010972BinaxNOW Influenza A & B Card 2Alere Scarborough, Inc.PSZ2019-07-15
10811877010989BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.PSZ2019-07-15
00895160002526Fluoro-CheckTM Influenza A+BNANO-DITECH CORPORATIONPSZ2019-05-24
10811877010422ID NOW Influenza A & B 2Alere Scarborough, Inc.PSZ2018-10-29
10811877010439ID NOW Influenza A & B Control Swab KitAlere Scarborough, Inc.PSZ2018-10-29
10854916006796MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
10854916006802MC3 Crescent Jugular Dual Lumen CatheterMICHIGAN CRITICAL CARE CONSULTANTS, INC.PSZ2018-07-30
00382902560715BD Veritor™ System CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYPSZ2018-05-25
00840733101649ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate KitMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12
00840733101656ImmunoCard STAT! FLU A&BMERIDIAN BIOSCIENCE, INC.PSZ2018-03-12
10811877010880Alere Influenza A & B Control Swab KitAlere Scarborough, Inc.PSZ2018-01-01