FDA.report

DrugCheck

Primary DI
B2983017010
Brand
DrugCheck
Company
Express Diagnostic Int'l, Inc.
Model
30170
Catalog number
30170
Device description
Single Dip Drug Test, BZO
Published
2019-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications

CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B2983017010PrimaryHIBCC0

GMDN Terms

TermDefinition
Benzodiazepine group 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 benzodiazepine 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

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
507-526-3951quality@drugcheck.com

Regulatory Flags

DUNS number
015875273
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 DIBrandModelCatalogPublished
B2986074060DrugCheck60740-660740-62026-03-09
B29880913EI0DrugCheck 80913-EI80913-EI2026-02-23
B2986051360DrugCheck 60513-660513-62026-02-20
B2987050460DrugCheck 70504-670504-62026-02-20
B29880502EI0DrugCheck 80502-EI80502-EI2026-02-20
B298307220DrugCheck 30722307222026-02-19
B298605010DrugCheck 60501605012026-02-19
B298606220DrugCheck 60622606222025-12-09
B298305250DrugCheck 30525305002023-11-30
B2986089051DrugCheck 60890-560890-52023-11-28
B2987050030DrugCheck 70500-370500-32023-08-28
B298606190DrugCheck60619606192023-04-14
B298608040DrugCheck60804608042022-10-14
B29880408EI0DrugCheck80408-EI80408-EI2022-10-12
B298605090DrugCheck60509605092022-07-27
B298607260DrugCheck60726607262022-07-22
B298610700DrugCheck61070610702022-07-22
B29830128C10DrugCheck30128C30128C2019-05-31
B298309130DrugCheck30913309132022-03-02
B29880628EI0DrugCheck80628-EI80628-EI2022-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10810173655993HealgenHealgen Scientific Limited Liability CompanyJXM2026-03-11
10810173655597HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
10810173655658HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
00810173655101HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-31
10810173655603HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
10810173655641HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
00810173654821HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00810173654838HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00850054026989QMedix™Diagnostic Automation, Inc.JXM2025-12-23
00850054026996QMedix™Diagnostic Automation, Inc.JXM2025-12-23
10810173654002HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654149HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654644HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
00850013035830Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCJXM2025-12-04
0081703802225210 Panel Drug Test CupUCP BIOSCIENCES, INC.JXM2025-03-24
10815845024305SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.JXM2024-12-17
00841824105409N/AW.H.P.M. INC.JXM2024-06-14
10810124273023SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273283SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273726CERTUM BZO One Step Benzodiazepines Test StripALERE SAN DIEGO, INC.JXM2023-12-15
00817763022367First SignHEMOSURE INC.JXM2023-05-18
04015630999347ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
07613336121054ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
00850041101750Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101781Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101798Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
10817405022936iCup™Instant Technologies, Inc.JXM2023-02-09
30817405022282iScreen™Instant Technologies, Inc.JXM2023-02-07
30817405022565iCassette™Instant Technologies, Inc.JXM2023-02-07
B77830573OD0Origin Instant Dip Drug TestORIGIN DIAGNOSTICS LLCJXM2022-12-07