FDA.reportPublic FDA data

co-innovation

Primary DI
06970429840423
Brand
co-innovation
Company
Co-Innovation Biotech Co., Ltd
Model
OPI Test Strip
Published
2017-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
PVHTest, Opiates, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970429840430PackageGS1100Not in Commercial Distribution
16970429840437PackageGS1100Not in Commercial Distribution
06970429840423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970429840430069704298404306970429840430
1697042984043716970429840437
06970429840423069704298404236970429840423

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an immunochromatographic test (ICT) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421302978
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970429840171co-innovationHCG TEST2023-04-28
06970429840195Flo12026-03-31
06970429844124Flo12026-03-31
06970429844117co-innovationLH TEST2025-10-20
06970429843417co-innovationCOT TEST2025-05-19
16970429843414co-innovationCOT TEST2025-05-19
06970429843318co-innovationFYL TEST2024-08-20
16970429843315co-innovationFYL TEST2024-08-20
06970429841345DTPM13P2023-12-08
06970429841635DTPM16P2023-12-08
16970429841342DTPM13P2023-12-08
16970429841632DTPM16P2023-12-08
06970429840102Co-innovationHCG Strip/4.0mm2017-03-23
06970429840119MomMedHCG TEST STRIP 2018-12-31
06970429840126AICAREHCG Pregnancy Test2019-03-18
06970429840133HealthyWiserHCG Test Strip2016-10-31
06970429840157HCG TEST STRIPHCG3.52019-12-25
06970429840164PREGABLE12021-06-02
06970429840300Co-innovationHCG Cassette2017-03-23
16970429840154HCG TEST STRIPHCG3.52019-12-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PVH2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVH2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVH2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVH2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVH2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVH2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPVH2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PVH2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVH2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVH2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVH2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVH2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVH2024-09-29