FDA.reportPublic FDA data

kangzhou

Primary DI
06923304623338
Brand
kangzhou
Company
Weihai Kangzhou Biotechnology Engineering Co., Ltd
Model
cassette
Published
2023-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06923304623338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923304623338069233046233386923304623338

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid/cannabinoid metabolite IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560448061
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923304600193U Pregnancy TestCassette2026-07-28
06923304600124FERTICAREmidstream2026-07-21
06923304600131FERTICAREmidstream2026-07-21
06923304600155FERTICAREmidstream2026-07-21
06923304600162FERTICAREmidstream2026-07-21
06923304600186FERTICAREmidstream2026-07-21
06923304611175FERTICAREMIDSTREAM2026-07-21
06923304611182FERTICAREmidstream2026-07-21
06923304611199FERTICARESTRIP2026-07-21
06923304611236FERTICAREMIDSTREAM2026-07-21
06923304611274FERTICAREMIDSTREAM2026-07-21
06923304611281FERTICAREmidstream2026-07-21
06923304611151FERTICAREstrip2026-01-21
06923304611120FERTICAREStrip2024-01-11
06923304611137FERTICAREmidstream2024-01-11
06923304600100FERTICARESTRIP2026-01-21
06923304600094Sims pregnancy test kitcassette2025-12-03
06923304611144Sims ovulation test kitcassette2025-12-03
06923304621136kangzhouCassette2024-04-24
06923304600087MaYamidstream2024-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B29880805EI0DrugCheckEXPRESS DIAGNOSTICS INT'L, INC.PVJ2026-09-18
B29881100AEI0DrugCheckExpress Diagnostic Int'l, Inc.PVJ2026-08-25
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-04-29
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVJ2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVJ2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVJ2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVJ2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVJ2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVJ2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVJ2025-06-20
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVJ2025-03-19
06977469280080U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVJ2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVJ2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVJ2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29
00850054867803AmazewellGuangzhou Decheng Biotechnology Co., LTDPVJ2024-09-29