FDA.reportPublic FDA data

Status™ COVID-19/Flu

Primary DI
10743816001553
Brand
Status™ COVID-19/Flu
Company
PRINCETON BIOMEDITECH CORPORATION
Model
BSP-511-25
Catalog number
BSP-511-25
Device description
Status™ COVID-19/Flu A&B Antigen test kit, 25 tests
Published
2021-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSZDevices Detecting Influenza A, B, And C Virus Antigens
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2
QKPCoronavirus Antigen Detection Test System.UnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251538000Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.2025-11-14SCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10743816001553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1074381600155310743816001553

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses to aid the diagnosis of coronavirus disease (COVID-19) infection. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-526-2125info@lifesignmed.com

Regulatory Flags#

DUNS number
362917692
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
10743816001621Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-01-00BSP-512-01-002023-10-20
10743816001638Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-02-00BSP-512-02-002023-10-20
10743816001645Status™ COVID-19 Antigen Rapid Test for Home UseBSP-512-25-00BSP-512-025-002023-10-20
10743816000532BioSign® hCG cardBSP-121-35-00BSP-121-35-002016-09-23
10743816000556Status hCG cardBSP-121-35-01BSP-121-35-012016-09-23
10743816000563Status hCG cardBSP-121-12-00BSP-121-12-002016-09-23
10743816000570BioSign® hCG cardBSP-121-35-03BSP-121-35-032016-09-23
10743816000587BioSign® hCG cardBSP-121-10-01BSP-121-10-012016-09-23
10743816000594Status hCG cardBSP-121-35-06BSP-121-35-062016-09-23
10743816000600BioSign® hCG cardBSP-121-35-07BSP-121-35-072016-09-23
10743816000617BioSign® hCG cardBSP-121-35-10BSP-121-35-102016-09-23
10743816000624Status hCG controlsBSP-121C-00BSP-121C-002016-09-23
10743816000631Status™ hCG S/U cardBSP-120S-35-01BSP-120S-35-012016-09-23
10743816000648Status™ hCG S/U cardBSP-120S-12-00BSP-120S-12-002016-09-23
10743816000655BioSign® hCG S/U cardBSP-120S-35-04BSP-120S-35-042016-09-23
10743816000662BioSign® hCG S/U cardBSP-120S-10-01BSP-120S-10-012016-09-23
10743816000679BioSign® hCG S/U cardBSP-120S-35-09BSP-120S-35-092016-09-23
10743816000686Status™ hCG S/U cardBSP-120S-10-03BSP-120S-10-032016-09-23
10743816000693StatusFirst™ hCG S/U cardBSP-122-35-02BSP-122-35-022016-09-23
10743816000709BioSign® RC hCG S/U cardBSP-122-35-00BSP-122-35-002016-09-23

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
B115ABCASS1CANAO25T1Advin COVID-19 Antigen Test @HomeADVIN BIOTECH, INC.QKP2025-12-29
50810172700074Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
60810172700071Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2025-08-01
00860013635107Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635114Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
00197644204359Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644380435Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00197644563371Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-01-15
00810143620184Genabio COVID-19 Rapid Self-Test KitGenabio Diagnostics Inc.QKP2025-01-13
00816862024609WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
10816862024606WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
00742860000027OSOM COVID-19 Antigen Rapid TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000034OSOM COVID-19 Antigen Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000041OSOM COVID-19 Antigen Home TestSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control KitSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo HomeSEKISUI DIAGNOSTICS, LLCQKP2024-12-16
50810172700081Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
50810172700098Speedy Swab Rapid COVID-19 & FLU A&B Self-Test WatMIND USAQKP2024-08-30
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08
00895160002847Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONPSZ2024-08-08
00810172700079Speedy Swab Rapid COVID-19 & FLU A+B (4 Tests/Box)WatMIND USAQKP2024-08-08
00810172700086Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestNANO-DITECH CORPORATIONQKP2024-08-08