FDA.reportPublic FDA data

BioTeke

Primary DI
86974541564409
Brand
BioTeke
Company
Bioteke Corporation (Wuxi) Co., Ltd.
Model
BTK-H2205
Catalog number
BTK-H2205
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974541564403PrimaryGS10
86974541564409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974541564403069745415644036974541564403
8697454156440986974541564409

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560011452
Device count
5
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
true
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
06974541564526BioTekeST9001-22025-01-09
06974541563031BioTeke ST7001-12023-02-14
06974541563048BioTeke ST7001-22023-02-14
06974541563086BioTeke ST8001-12023-02-16
06974541563109BioTeke ST8001-22023-02-16
06974541563116BioTeke ST8001-22023-02-16
06974541563147BioTeke ST9001-12023-02-16
06974541563154BioTeke ST9001-12023-02-16
06974541564069BioTekeST9001-22023-02-08
06974541564403BioTekeBTK-H2205BTK-H22052024-05-27
06974541564397BioTekeBTK-H2201BTK-H22012023-09-12
06974541564380BioTekeBTK-H2202BTK-H22022023-09-04
06974541563024BioTeke ST7001-12023-02-14
06974541563055BioTeke ST7001-22023-02-16
06974541563093BioTeke ST8001-12023-02-16
06974541564373biotekeST9001-22023-05-05
06974541564335BioTeke ST7001-12023-03-07
06974541564342BioTeke ST7001-12023-03-07
86974541564331BioTeke ST7001-12023-03-07
06974541564359BioTeke ST7001-22023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10810172700083RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
10810172700090RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)WatMIND USAQKP2024-08-08
20810172700080RDB6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)WatMIND USAQKP2024-08-08
20810172700097RDB10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test WatMIND USAQKP2024-08-08
30810172700087CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08
30810172700094CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08
40810172700084CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)WatMIND USAQKP2024-08-08