FDA.reportPublic FDA data

iCup®

Primary DI
10817405021335
Brand
iCup®
Company
Instant Technologies, Inc.
Model
DPG-1117-141
Catalog number
DPG-1117-141
Device description
iCup® E&I Urine Test 11 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/BAR300/BZO300/BUP10/COC300/MTD300/MET1000/MDMA500/OPI2000/OXY100/PCP25)
Published
2021-09-20
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
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817405021335PrimaryGS10
00817405021338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081740502133510817405021335
00817405021338008174050213388174050213380817405021338

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
Handling Environment Temperature2 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
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
G474M3209010VerifyMlife Diagnostics, LLCPUX2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUZ2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUY2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUX2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVA2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUZ2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUY2025-07-21
G474M3106010ClassicMlife Diagnostics, LLCPVA2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVH2025-06-20