FDA.reportPublic FDA data

ETERBIO Fentanyl/Norfentanyl Home Test

Primary DI
06977469280431
Brand
ETERBIO Fentanyl/Norfentanyl Home Test
Company
Eterbio, Inc.
Model
ETG001003
Device description
3 tests/Kit
Published
2025-12-08
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
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243064000ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.2024-11-20NGL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977469280431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977469280431069774692804316977469280431

GMDN Terms#

Term, Definition table
TermDefinition
Fentanyl 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 fentanyl 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)ETG0190052024-12-18
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
00311917077932WalgreensWALGREEN CO.NGL2026-10-14
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NGL2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NGL2026-10-13
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test DipstickHangzhou AllTest Biotech Co., Ltd.NGL2026-10-12
10722066005511Rapid ResponseBTNX IncNGL2026-10-09
10722066018979Rapid ResponseBTNX IncNGL2026-10-08
10722066019013Rapid ResponseBTNX IncNGL2026-10-08
10722066019020Rapid ResponseBTNX IncNGL2026-10-08
10722066019037Rapid ResponseBTNX IncNGL2026-10-08
10722066019044Rapid ResponseBTNX IncNGL2026-10-08
10722066018955Rapid ResponseBTNX IncNGL2026-10-06
10722066018696Rapid ResponseBTNX IncNGL2026-09-18
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
06936983113953Alltest MOP300 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114103Alltest MOP300 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114127Alltest MOP2000 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114134Alltest OXY100 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114202Alltest BUP10 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114226Alltest OXY100 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114240Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114301Alltest MOP2000 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114325Alltest MOP300 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114400Alltest MOP2000 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114417Alltest OXY100 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21
06936983114462Alltest BUP10 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NGL2026-04-21