FDA.reportPublic FDA data

iScreen™

Primary DI
10817405021380
Brand
iScreen™
Company
Instant Technologies, Inc.
Model
TDOA-XC10A
Catalog number
TDOA-XC10A
Device description
iScreen™ Urine Test Visual X Drug Screen Cup 10 Panel with Adulterants E&I (OX/pH/CR)(AMP500/BAR300/BZO300/THC50/COC150/MTD300/MET500/OPI2000/OXY100/PCP25)
Published
2021-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCMEnzyme Immunoassay, Phencyclidine
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
PVETest, Methadone, Employment And Insurance Testing, Exempt
PVHTest, Opiates, Employment And Insurance Testing, Exempt
PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PUYTest, Barbiturate, Employment And Insurance Testing, ExemptClinical Toxicology2
PUZTest, Benzodiazepine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClinical Toxicology2
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVETest, Methadone, Employment And Insurance Testing, ExemptClinical Toxicology2
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2
PVJTest, Cannabinoid, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817405021380PrimaryGS10
00817405021383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081740502138010817405021380
00817405021383008174050213838174050213830817405021383

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-340-4029Qa.Portsmouth@abbott.com

Regulatory Flags#

DUNS number
019410187
Device count
25
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817405024025iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
00817405021154UScreen®USSCup-10MUSSCup-10M2021-01-13
00817405021192UScreen®USSCupA-12CLIAUSSCUPA-12CLIA2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
10817405021304iScreen™IS1 MET-DX2 IS1 MET-DX2 2020-08-21
10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021328iScreen™IS12BUP-DX2 IS12BUP-DX2 2020-08-21
10817405021373UScreen®USSCupA-11CLIALCUSSCupA-11CLIALC2021-05-25
00817405022229iScreen™ABTDUAW110704DABTDUAW110704D2022-06-16
00817405023240iScreen™ABTDUAW112701AABTDUAW112701A2022-11-09
00817405023257iScreen™ABTDUAW16701AABTDUAW16701A2022-11-09
00817405023264iScreen™ABTDUAW17701AABTDUAW17701A2022-11-09
00817405023271iScreen™ABTDUAW110701AABTDUAW110701A2022-11-09
00817405023288iScreen™ABTDUAW110702BABTDUAW110702B2022-11-09
00817405023295iScreen™ABTDUAW15701AABTDUAW15701A2022-11-09
00817405023301iScreen™ABTDUAW113701AABTDUAW113701A2023-02-10
00817405023318iScreen™ABTDOAW14701AABTDOAW14701A2022-11-09
00817405023325iScreen™ABTDUAW17702BABTDUAW17702B2022-11-09
00817405023332iScreen™ABTDOAW17701AABTDOAW17701A2022-11-09
00817405023349iScreen™ABTDUAW110703CABTDUAW110703C2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVJ2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
G474M3209010VerifyMlife Diagnostics, LLCPVJ2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUY2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUZ2025-09-05