FDA.reportPublic FDA data

PreChek

Primary DI
00857275007421
Brand
PreChek
Company
IDUN SOLUTIONS LLC
Model
21512050010308
Device description
12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10)
Published
2018-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153050000Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.2016-04-26DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857275007421PackageGS125In Commercial Distribution
00857275007520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857275007421008572750074218572750074210857275007421
00857275007520008572750075208572750075200857275007520

GMDN Terms#

Term, Definition table
TermDefinition
Buprenorphine IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080651010
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00857275007544PreKnow211000154105082018-08-02
00857275007100PreKnow Pregnancy Test (25 hCG Strips)ID1-S-25P2017-05-16
00857275007735PreKnow211000154103082018-10-15
00857275007162PreChek Multi-Drug Test CupIDOA-7225RC-5P2018-06-20
00857275007520PreChek215120500103082018-08-02
00857275007575PreChek21512050010308-A2018-08-02
90857275007837Wholepower415111040010342019-09-02
00857275007797N/M125113150000342019-08-26
00857275007285PreChek Multi-Drug Test Square CupIDOA-7325SC-25P2018-06-20
00857275007179PreKnowIDOA-7562018-05-22
00857275007186PreKnowIDOA-31052018-05-23
00857275007513PreKnow215050400103082018-08-02
00857275007537PreKnow21115061010308-B2018-08-02
90857275007813N/M125111050000342019-08-26
00857275007124Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)IDTH-115-15P2017-05-16
00857275007131Preknow Multi-Drug (AMP/BZO/COC/OPI/THC) Screen Test (5 Dipcards)IDOA-755-5P2017-05-16
00857275007506PreKnow211150610103082018-08-02
00857275007568PreKnow21505040010308-C2018-08-02
00857275007551PreKnow211030154105082018-08-02
00857275007490PreKnow211140616103082018-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDJR2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDJR2021-06-24
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDJR2019-03-11
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2019-02-12
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDJR2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJR2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJR2018-03-30