FDA.report

INDICAID COVID-19 Rapid Antigen Test

Primary DI
04897116730985
Brand
INDICAID COVID-19 Rapid Antigen Test
Company
PHASE SCIENTIFIC INTERNATIONAL LIMITED
Model
25-Test
Published
2024-01-01
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

Related Records

Product Codes

CodeName
QKPCoronavirus Antigen Detection Test System.

Product Code Classifications

CodeDeviceSpecialtyClass
QKPCoronavirus Antigen Detection Test System.UnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04897116730985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04897116730985048971167309854897116730985

GMDN Terms

TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinicalA 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 used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods

Method

Regulatory Flags

DUNS number
664608670
Device count
1
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 DIBrandModelCatalogPublished
04897116730947INDICAID COVID-19 Rapid Antigen At-Home Test2-Test2024-01-01
04897116730954INDICAID COVID-19 Rapid Antigen At-Home Test4-Test2024-01-01
04897116730961INDICAID COVID-19 Rapid Antigen At-Home Test12-Test2024-01-01
04897116730978INDICAID COVID-19 Rapid Antigen At-Home Test24-Test2024-01-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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
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00860013635121Bio-Self COVID-19 Antigen Home TestBIOTEKE USA, LLCQKP2025-03-03
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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
10816862024606WELLlife™ WONDFO USA CO., LTD.QKP2024-12-20
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
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
40810172700091CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)WatMIND USAQKP2024-08-08
86974541564409BioTekeBioteke Corporation (Wuxi) Co., Ltd.QKP2024-05-27
10850044118424iHealthIHEALTH LAB INC.QKP2024-05-25
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04897116730947INDICAID COVID-19 Rapid Antigen At-Home TestPHASE SCIENTIFIC INTERNATIONAL LIMITEDQKP2024-01-01
04897116730954INDICAID COVID-19 Rapid Antigen At-Home TestPHASE SCIENTIFIC INTERNATIONAL LIMITEDQKP2024-01-01
04897116730961INDICAID COVID-19 Rapid Antigen At-Home TestPHASE SCIENTIFIC INTERNATIONAL LIMITEDQKP2024-01-01