FDA.reportPublic FDA data

STATDIP®

Primary DI
00816036020000
Brand
STATDIP®
Company
MICRO DISTRIBUTING, L.C
Model
DAM-114
Catalog number
DAM-114
Device description
STAT DOA Single CLIA Waived Test Dipcard, 25Pcs/Box AMP
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036020000PrimaryGS10
00816036020017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036020000008160360200008160360200000816036020000
00816036020017008160360200178160360200170816036020017

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 a specific amphetamine 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
866-933-0964info@micro-distributing.com

Regulatory Flags#

DUNS number
087732173
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816036026613STATCUP® SCP-32107-0-ASCP-32107-0-A2020-03-17
00816036026668STATCUP® SCP-31107-0SCP-31107-02021-01-14
00816036026569STATCUP® SCP-31107-0-ASCP-31107-0-A2019-07-02
00816036025432STATCUP® IISTAII-3187-0STATII-3187-02020-03-23
00816036025456STATCUP® IISTAII-03107-0-ASTAII-03107-0-A2021-08-03
00816036025470STATCUP® IISTATII-0247-0STATII-0247-02022-02-09
00816036025951STATDIP®DTH-40-0DTH-40-02020-06-02
00816036026590STATCUP® SCP-6157-0-ASCP-6157-0-A2020-03-17
00816036026606STATCUP® SCP-6167-0-ASCP-6167-0-A2020-03-17
00816036026620STATCUP® SCP-2277-0-ASCP-2277-0-A2020-09-09
00816036026637STATCUP® SCP-51127-0-ASCP-51127-0-A2020-09-28
00816036026644STATCUP® SCP-6157-0SCP-6157-02021-01-14
00816036026651STATCUP® SCP-2387-0-ASCP-2387-0-A2021-01-14
00816036026675STATCUP® SCP-21107-0-ASCP-21107-0-A2022-03-24
00816036027504STATSWAB3SS3-058SS3-0582021-09-16
00816036027511STATSWAB3SS3-158SS3-1582021-09-16
00816036027528STATSWAB3SS3-168SS3-1682021-09-16
00816036027535STATSWAB3SS3-048SS3-0482021-11-09
00816036027542STATSWAB3SS3-068SS3-0682021-11-09
00816036025487STATCUP® SCP-2397-0-ASCP-2397-0-A2023-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841824101845ECOIIW.H.P.M. INC.DKZ2026-03-19
B2986051360DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B2987050460DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-20
B298307220DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
B298605010DrugCheck Express Diagnostic Int'l, Inc.DKZ2026-02-19
10810173655665HealgenHealgen Scientific Limited Liability CompanyDKZ2026-01-30
B298606220DrugCheck Express Diagnostic Int'l, Inc.DKZ2025-12-09
00841824105706N/AW.H.P.M. INC.DKZ2025-12-04
00850013035748Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDKZ2025-12-04
00841824105683EZ CLICKW.H.P.M. INC.DKZ2025-11-20
00850721007501Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDKZ2025-09-11
00850076289003Hysen Drug Test CupsHYSEN INC.DKZ2025-08-04
00850076289010Hysen Drug Test CardsHYSEN INC.DKZ2025-08-04
208170380222709 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2025-06-06
208170380222875 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2025-06-06
20817038022263u-CupTM Drug Test ScreenUCP BIOSCIENCES, INC.DKZ2025-04-09
00858886006841Noble Drug Test Cup (Urine)NOBLE MEDICAL INCDKZ2025-01-17
10815845024381SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DKZ2024-12-17
10810124273160SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273177SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273658SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
10810124273665SureStep™ Urine Test E-Z Split Key™ Drug Screen CupALERE SAN DIEGO, INC.DKZ2024-09-17
00841824105553ECOIIW.H.P.M. INC.DKZ2024-08-22
00841824104730EZ CLICKW.H.P.M. INC.DKZ2024-07-25
10840050517496Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10840050517526Precision Plus Multi Panel Urine Drug Test CupADVIN BIOTECH, INC.DKZ2024-05-23
10816862024286T-DipWONDFO USA CO., LTD.DKZ2024-05-17
20817038022249inSight 12 Panel Drug Test CupUCP BIOSCIENCES, INC.DKZ2024-05-16
00841824105492ECOIIW.H.P.M. INC.DKZ2024-04-26
20817038022225OEM 81-13 Drug Test 5 Panel Test CupUCP BIOSCIENCES, INC.DKZ2024-04-09