FDA.reportPublic FDA data

STATCUP®

Primary DI
00816036021625
Brand
STATCUP®
Company
MICRO DISTRIBUTING, L.C
Model
SCP-31107
Catalog number
SCP-31107
Device description
STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP//PPX/THC/
Published
2021-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKEReagents, Test, Tetrahydrocannabinol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036021403PrimaryGS10
00816036021625Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036021403008160360214038160360214030816036021403
00816036021625008160360216258160360216250816036021625

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 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. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
087732173
Device count
25
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

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
00690286000773PROFILE®-IIAMEDTOX DIAGNOSTICS, INC.DKE2023-06-01
00690286000780PROFILE-II ER®MEDTOX DIAGNOSTICS, INC.DKE2023-06-01
10796918002447Multi-Drug of Abuse Urine Cup TestALFA SCIENTIFIC DESIGNS, INC.DKE2022-11-07
10796918002430Instant-View Multi-Drug of Abuse Urine Cup Test AMP BZD COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2021-09-24
10796918002423INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-29
10796918002416INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MET,MOR, MTD, OXY, TALFA SCIENTIFIC DESIGNS, INC.DKE2021-07-12
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKE2021-06-24
10796918002201INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300ALFA SCIENTIFIC DESIGNS, INC.DKE2021-04-21
10796918002195INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BUP, BZD, COC, MOR30ALFA SCIENTIFIC DESIGNS, INC.DKE2020-09-14
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2019-09-28
10796918002188INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-09-23
10796918002171INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-06-12
10796918002133INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR, THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-03
10796918002089INSTANT-VIEW Multi-Drugs of Abuse Urine TestALFA SCIENTIFIC DESIGNS, INC.DKE2019-05-01
10796918002102Instant-View Multi-Drug of Abuse Urine Cup Test AMP COC MET MOR/OPI PCP THCALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-29
10796918002058INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10796918002065INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)ALFA SCIENTIFIC DESIGNS, INC.DKE2019-03-26
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKE2019-03-11
10796918002041INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR200ALFA SCIENTIFIC DESIGNS, INC.DKE2019-02-06
10796918002010INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10796918002027INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test ALFA SCIENTIFIC DESIGNS, INC.DKE2018-12-14
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-10-29
10796918001983INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, THC, XTC ALFA SCIENTIFIC DESIGNS, INC.DKE2018-08-28
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2018-04-19
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONDKE2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKE2017-10-12