FDA.reportPublic FDA data

THE SOLUTION

Primary DI
30681066053998
Brand
THE SOLUTION
Company
Sakar International, Inc.
Model
139AUCMUC03
Published
2022-07-12
Public version status
New
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

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
00681066053997PrimaryGS10
30681066053998Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681066053997006810660539976810660539970681066053997
3068106605399830681066053998

Sterilization Methods#

Method table
Method

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
00021331054500THE SOLUTION150AUCMUC142022-07-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G754QTUCUP10BU1QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
G754QTUCUP5C31QuikTox Ultra Cup Rapid Drug TestADVIN BIOTECH, INC.NFT2026-10-30
06978151200287Pocguide Multi-Drug Test Panel OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
06978151200294Pocguide Multi-Drug Test Cup OTCHangzhou Aichek Medical Technology Co., Ltd.NFT2026-10-27
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