Home GUDID 00816862024975 SAFElife™
Primary DI 00816862024975
Brand SAFElife™
Company WONDFO USA CO., LTD.
Model WDFT-201-OTC1-10BX
Device description 1-Cassette; FTY Fentanyl 1 ng/ml OTC; 10 Tests/Kitbox
Published 2024-12-24
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 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 10816862024972 Package GS1 72 In Commercial Distribution 00816862024975 Primary GS1 0 00816862024968 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 10816862024972 10816862024972 00816862024975 00816862024975 816862024975 0816862024975 00816862024968 00816862024968 816862024968 0816862024968
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 10 Lot or batch true Expiration date on label true 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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