FDA.reportPublic FDA data

Buprenorphine/Methadone Panel Dip

Primary DI
06952804801397
Brand
Buprenorphine/Methadone Panel Dip
Company
ASSURE TECH. (HANGZHOU) CO., LTD.
Model
1.0
Published
2017-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152025000AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Assure Tech. Co., Ltd.2015-10-05DJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06952804801397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06952804801397069528048013976952804801397

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
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
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
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
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00810173656733HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJG2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
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