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
00850076289706HYSEN Multiple Drugs Test CupHYSEN INC.NGL2026-07-20
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G474M2105010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2107010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2113010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2116010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
G474M2117010mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-07-20
10722066018009Rapid ResponseBTNX IncNGL2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
10722066015053Rapid ResponseBTNX IncNGL2026-05-15
10722066015084Rapid ResponseBTNX IncNGL2026-05-15
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NGL2026-04-16
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