FDA.reportPublic FDA data

Premier Bio-Cup & Bio-Dip

Primary DI
B313PBCARD01BZO3001
Brand
Premier Bio-Cup & Bio-Dip
Company
PREMIER BIOTECH, INC
Model
PBCard-01-BZO300
Catalog number
PBCard-01-BZO300
Device description
BZO300
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
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical 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
B313PBCARD01BZO3001PrimaryHIBCC0
B313PBCARD01BZO3000Unit 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
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
B313PBCARD03041Premier Bio-Cup & Bio-DipPBCard-03-04PBCard-03-042017-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.JXM2024-02-09
16936983149744Discover milti-drug 7 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.JXM2024-02-08
16936983150634Discover milti-drug 8 drugs rapid test cup (urine)Hangzhou AllTest Biotech Co., Ltd.JXM2024-02-08
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