Reveal

Primary DI
10840050502430
Brand
Reveal
Company
AMERICAN SCREENING, L.L.C.
Model
ASC-RDUD-3124N
Published
2022-11-11
Public version status
Update
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840050502430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084005050243010840050502430

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.

Regulatory Flags#

DUNS number
169065054
Device count
1
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#

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
00840050500170OneScreenAMERICAN SCREENING, L.L.C.QBF2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.QAW2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFT2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGM2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTG2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.QAW2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.QBF2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.QAW2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.PTH2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGG2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.QBF2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFY2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFW2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NFV2022-11-11