FDA.reportPublic FDA data

STATDIP®

Primary DI
00816036020246
Brand
STATDIP®
Company
MICRO DISTRIBUTING, L.C
Model
SDP-254
Catalog number
SDP-254
Device description
STAT DOA 5 in1 CLIA Waived Test Dipcard, 25Pcs/BoxAMP/COC/mAMP/OPI/THC
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJCThin Layer Chromatography, Metamphetamine
DJGEnzyme Immunoassay, Opiates
DKEReagents, Test, Tetrahydrocannabinol
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036020246PrimaryGS10
00816036020628Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036020246008160360202468160360202460816036020246
00816036020628008160360206288160360206280816036020628

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.

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
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIO2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2016-09-23
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDIO2016-09-23
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2016-09-23