FDA.reportPublic FDA data

THE SOLUTION

Primary DI
00021331054500
Brand
THE SOLUTION
Company
Sakar International, Inc.
Model
150AUCMUC14
Published
2022-07-12
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFTTest, Amphetamine, Over The CounterClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00021331054500PrimaryGS10
30021331054501Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00021331054500000213310545000213310545000021331054500
3002133105450130021331054501

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
086413028
Device count
2
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
false
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
00681066049600THE SOLUTION105THCSTR032022-07-12
00681066053706THE SOLUTION160THCDCA062022-07-12
00681066053997THE SOLUTION139AUCMUC032022-07-12
00681066089583BrookstoneBRH-0072023-09-27
00681066089590BrookstoneBRH-1182023-09-27
00681066089606BrookstoneBRH-1202023-09-27
00681066089613BrookstoneBRH-1242023-09-27
30681066089584BrookstoneBRH-0072023-09-27
30681066089591BrookstoneBRH-1182023-09-27
30681066089607BrookstoneBRH-1202023-09-27
30681066089614BrookstoneBRH-1242023-09-27
30021331054501THE SOLUTION150AUCMUC142022-07-12
30681066049601THE SOLUTION105THCSTR032022-07-12
30681066053707THE SOLUTION160THCDCA062022-07-12
30681066053998THE SOLUTION139AUCMUC032022-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937339211507BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06937339211538BioSieveVivachek Biotech (Hangzhou) Co., Ltd.NFT2026-10-14
06974541566049BioTekeBioteke Corporation (Wuxi) Co., Ltd.NFT2026-10-13
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNFT2026-08-14
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114196Alltest AMP500 Rapid Test Dipstick (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114455Alltest AMP500 Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114592Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983114608Alltest AMP500 Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-21
06936983113878Alltest AMP500 Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-17
16936983131633Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114790Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114806Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114813Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114820Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114837Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114844Alltest Multi-Drug 12 Drugs Rapid Test Cup (Urine)-CLIA WaivedHangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114868Alltest Multi-Drug 15 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983114875Alltest Multi-Drug 15 Drugs Rapid Test Panel (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983118064Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983118071Alltest Multi-Drug 12 Drugs Home Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
06936983125123Multi-Drug 12 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine)Hangzhou AllTest Biotech Co., Ltd.NFT2026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.NFT2026-04-15