FDA.reportPublic FDA data

STATSWAB®

Primary DI
00816036028624
Brand
STATSWAB®
Company
MICRO DISTRIBUTING, L.C
Model
SSB-0108
Catalog number
SSB-0108
Device description
STATSWAB saliva device, 25Pcs/BoxAMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP
Published
2021-04-27
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
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
PVETest, Methadone, Employment And Insurance Testing, Exempt
PVHTest, Opiates, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PUYTest, Barbiturate, Employment And Insurance Testing, ExemptClinical Toxicology2
PUZTest, Benzodiazepine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, ExemptClinical Toxicology2
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2
PVETest, Methadone, Employment And Insurance Testing, ExemptClinical Toxicology2
PVHTest, Opiates, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036028624PrimaryGS10
00816036029126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036028624008160360286248160360286240816036028624
00816036029126008160360291268160360291260816036029126

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVH2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVA2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVA2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVH2026-04-03
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVA2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVH2026-01-29
G474M3209010VerifyMlife Diagnostics, LLCPUX2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVA2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUZ2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPUY2025-09-05
G474M3209010VerifyMlife Diagnostics, LLCPVH2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVH2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUX2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVA2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUZ2025-07-21
G474M3208010VerifyMlife Diagnostics, LLCPUY2025-07-21
G474M3106010ClassicMlife Diagnostics, LLCPVA2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20
G474M3106010ClassicMlife Diagnostics, LLCPVH2025-06-20