FDA.reportPublic FDA data

S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)

Primary DI
06977469280219
Brand
S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)
Company
Eterbio, Inc.
Model
ETG019005
Device description
5 Tests/Kit;6 Panel;AMP50,BZO50,COC50,MET25,OPI40,THC50
Published
2024-12-18
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
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
PVHTest, Opiates, Employment And Insurance Testing, Exempt
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PUZTest, Benzodiazepine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClinical Toxicology2
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977469280219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977469280219069774692802196977469280219

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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 table
Method

Regulatory Flags#

DUNS number
638595825
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
06977469280431ETERBIO Fentanyl/Norfentanyl Home TestETG0010032025-12-08
06977469280011U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)ETG0040012024-12-17
06977469280042U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)ETG0040252024-12-17
06977469280080U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)ETG0210102024-12-18
06977469280097U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)ETG0220102024-12-18
06977469280158U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) ETG0220202024-12-18
06977469280189U-Catch XR Multi-Drug Test Cup(Colloidal Gold)ETG0110252024-12-18
06977469280004U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold)ETG0040052024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-01-29
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUZ2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUX2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVJ2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVA2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUX2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUZ2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20