FDA.report

MD DugScreen

Primary DI
00850969007653
Brand
MD DugScreen
Company
MEDICAL DISPOSABLES CORP
Model
M-DBZ-114
Device description
CLIA Waived Benzodiazepine Test Panel (BZO)
Published
2017-03-31
Public version status
Update
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

Product Codes

CodeName
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications

CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850969007653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850969007653008509690076538509690076530850969007653

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961673774
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

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00810143450064MD EndoGuidanceMD12-1002023-07-31
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00810143450125MD EndoGuidanceMD5-1502023-07-31
00810143450156MD EndoGuidanceMD10-1502023-07-31
00810143450187MD EndoGuidanceMD12-150 2023-07-31
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Other Devices Sharing Product Codes

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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
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00850041101750Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
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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