FDA.reportPublic FDA data

Morphine300 Panel Dip

Primary DI
06952804801809
Brand
Morphine300 Panel Dip
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Published
2017-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGLTest, Opiates, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGLTest, Opiates, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170049000AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd.2017-05-02NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952804801809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804801809069528048018096952804801809

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of opiate and/or opiate metabolites in a clinical specimen, using an immunochromatographic test (ICT) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530757741
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26952804809700Multi-dip Drugs Test (BZO 300 Dip Card)1.02026-02-10
16952804808324Multi-Panel Drug Test Cup1.02025-03-18
06952804802608AssureTech Panel Dip Tests1.02018-09-04
06952804802615AssureTech Quick Cup Tests1.02018-09-04
06952804802622AssureTech Panel Dip Tests1.02018-09-04
06952804802639AssureTech Quick Cup Tests1.02018-09-04
26952804810461Marijuana Test Strip1.02025-03-18
06952804801175Methamphetamine Strip1.02017-02-06
06952804801182Phencyclidine Strip1.02017-02-06
06952804801199Marijuana Strip1.02017-02-06
06952804801458Methamphetamine/Phencyclidine/Marijuana Panel Dip1.02017-02-07
06952804801465Methamphetamine/Phencyclidine/Marijuana Quick Cup1.02017-02-07
06952804801472Methamphetamine/Phencyclidine/Marijuana Turnkey Split Cup1.02017-02-07
06952804801779Methamphetamine Panel Dip1.02017-07-24
06952804801786Phencyclidine Panel Dip1.02017-07-24
06952804801793Marijuana Panel Dip1.02017-07-24
06952804801090hCG Pregnancy Test Cassette1.02016-09-24
06952804801205hCG Pregnancy Serum/Urine Combo Test Cassette1.0HCG-C232017-02-04
06952804801212HCG Pregnancy Test Strip1.02016-09-24
06952804801830hCG Pregnancy Serum/Urine Combo Test Strip(10/20)1.02017-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M210501EI0mLife Rapid Drug TestMlife Diagnostics, LLCNGL2026-08-14
00840050500170OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500187OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500194OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500200OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500217OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500224OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500231OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500248OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500255OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500262OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500279OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500286OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500293OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500309OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500316OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500323OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500330OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500347OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500354OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500361OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500378OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500385OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500392OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500408OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500415OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500422OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500439OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500446OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11
00840050500453OneScreenAMERICAN SCREENING, L.L.C.NGL2022-11-11