Home GUDID 10816862025894 SAFElife™
Primary DI 10816862025894
Brand SAFElife™
Company WONDFO USA CO., LTD.
Model WFTY-OTC1-25BX
Device description 1-Panel Card; FTY Fentanyl 1 ng/ml OTC; 25 Tests/Kitbox
Published 2024-12-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NGL Test, Opiates, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NGL Test, Opiates, Over The Counter Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10816862025894 Package GS1 45 In Commercial Distribution 00816862025897 Primary GS1 0 00816862025880 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10816862025894 10816862025894 00816862025897 00816862025897 816862025897 0816862025897 00816862025880 00816862025880 816862025880 0816862025880
GMDN Terms# Term, Definition table Term Definition Fentanyl IVD, kit, rapid ICT, clinical A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 849098897 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840050500170 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500187 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500194 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500200 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500217 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500224 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500231 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500248 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500255 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500262 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500279 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500286 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500293 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500309 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500316 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500323 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500330 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500347 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500354 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500361 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500378 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500385 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500392 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500408 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500415 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500422 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500439 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500446 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500453 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11 00840050500460 OneScreen AMERICAN SCREENING, L.L.C. NGL 2022-11-11
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