FDA.reportPublic FDA data

Premier Bio-Cup & Bio-Dip

Primary DI
B313PBCUP09061
Brand
Premier Bio-Cup & Bio-Dip
Company
PREMIER BIOTECH, INC
Model
PBCup-09-06
Catalog number
PBCup-09-06
Device description
AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50
Published
2017-09-25
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122809000Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013-06-17DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B313PBCUP09061PrimaryHIBCC0
B313PBCUP09060Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010118759
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B313OT804011OralToxOT804012018-09-24
B313OT804021OralToxOT804022018-09-27
B313OT804041OralToxOT804042018-09-24
B313OT805021OralToxOT805022018-09-24
B313OT805041OralToxOT805042018-09-24
B313OT805081OralToxOT805082018-09-24
B313OT805091OralToxOT805092018-09-24
B313OT805101OralToxOT805102018-09-24
B313OT806021OralToxOT806022018-09-24
B313OT806051OralToxOT806052018-09-24
B313OT806221OralToxOT806222018-09-24
B313OT807011OralToxOT807012018-09-24
B313OT808071OralToxOT808072018-09-24
B313PBCARD01AMP5001Premier Bio-Cup & Bio-DipPBCard-01-AMP500PBCard-01-AMP5002018-01-23
B313PBCARD01BAR3001Premier Bio-Cup & Bio-DipPBCard-01-BAR300PBCard-01-BAR3002017-09-25
B313PBCARD01BZO3001Premier Bio-Cup & Bio-DipPBCard-01-BZO300PBCard-01-BZO3002017-09-25
B313PBCARD01COC1501Premier Bio-Cup & Bio-DipPBCard-01-COC150PBCard-01-COC1502017-09-25
B313PBCARD01OPI20001Premier Bio-Cup & Bio-DipPBCard-01-OPI2000PBCard-01-OPI20002017-09-25
B313PBCARD01PCP1Premier Bio-Cup & Bio-DipPBCard-01-PCPPBCard-01-PCP2017-09-25
B313PBCARD01THC501Premier Bio-Cup & Bio-DipPBCard-01-THC50PBCard-01-THC502017-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIS2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyLCM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
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10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
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10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLCM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
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10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
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