FDA.reportPublic FDA data

Reveal

Primary DI
00840050503003
Brand
Reveal
Company
AMERICAN SCREENING, L.L.C.
Model
ASC-RMCUP-754T
Published
2022-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
NGMTest, Phencyclidine (Pcp), Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter
QBFTest, Propoxyphene, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
NGMTest, Phencyclidine (Pcp), Over The CounterUnknownU
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2
QBFTest, Propoxyphene, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180349000AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.2018-04-05NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840050503003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840050503003008400505030038400505030030840050503003

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
169065054
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840050500170OneScreenASC-CUP-00122022-11-11
00840050500187OneScreenASC-CUP-00122022-11-11
00840050500194OneScreenASC-CUP-141042022-11-11
00840050500200OneScreenASC-CUP-141042022-11-11
00840050500217OneScreenASC-CUP-21242022-11-11
00840050500224OneScreenASC-CUP-21242022-11-11
00840050500231OneScreenASC-CUP-2542022-11-11
00840050500248OneScreenASC-CUP-2542022-11-11
00840050500255OneScreenASC-CUP-31042022-11-11
00840050500262OneScreenASC-CUP-31042022-11-11
00840050500279OneScreenASC-CUP-31242022-11-11
00840050500286OneScreenASC-CUP-31242022-11-11
00840050500293OneScreenASC-CUP-51042022-11-11
00840050500309OneScreenASC-CUP-51042022-11-11
00840050500316OneScreenASC-DAM-1142022-11-11
00840050500323OneScreenASC-DAM-1142022-11-11
00840050500330OneScreenASC-DBA-1142022-11-11
00840050500347OneScreenASC-DBA-1142022-11-11
00840050500354OneScreenASC-DBZ-1142022-11-11
00840050500361OneScreenASC-DBZ-1142022-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10648564316280SnapCheckDx Rapid Urine THC TestHangzhou Aichek Medical Technology Co., Ltd.NFW2026-05-12
10197344170203MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-29
10197344170210MEDLINEMEDLINE INDUSTRIES, INC.NFT2026-01-23
10722066011260Rapid ResponseBTNX IncNGM2026-01-19
10722066011260Rapid ResponseBTNX IncNFW2026-01-19
10722066011260Rapid ResponseBTNX IncNFV2026-01-19
10722066011260Rapid ResponseBTNX IncNGL2026-01-19
10722066011260Rapid ResponseBTNX IncPTG2026-01-19
10722066011260Rapid ResponseBTNX IncNGG2026-01-19
10722066011260Rapid ResponseBTNX IncNFY2026-01-19
10722066011260Rapid ResponseBTNX IncQBF2026-01-19
10722066011260Rapid ResponseBTNX IncPTH2026-01-19
10722066011260Rapid ResponseBTNX IncQAW2026-01-19
10722066009083Rapid ResponseBTNX IncPTG2025-10-03
10722066009083Rapid ResponseBTNX IncNGG2025-10-03
10722066009083Rapid ResponseBTNX IncNFW2025-10-03
10722066009083Rapid ResponseBTNX IncNGL2025-10-03
10722066009083Rapid ResponseBTNX IncPTH2025-10-03
10722066009083Rapid ResponseBTNX IncNGM2025-10-03
10722066009083Rapid ResponseBTNX IncQAW2025-10-03
10722066009083Rapid ResponseBTNX IncNFY2025-10-03
10722066009083Rapid ResponseBTNX IncNFV2025-10-03
10722066010973Rapid ResponseBTNX IncNGG2025-07-08
10722066010973Rapid ResponseBTNX IncNFY2025-07-08
10722066010973Rapid ResponseBTNX IncPTH2025-07-08
10722066010973Rapid ResponseBTNX IncNGL2025-07-08
10722066010973Rapid ResponseBTNX IncPTG2025-07-08
10722066010973Rapid ResponseBTNX IncNGM2025-07-08
10722066010973Rapid ResponseBTNX IncNFW2025-07-08
10722066010973Rapid ResponseBTNX IncNFV2025-07-08