FDA.reportPublic FDA data

STATSWABII®

Primary DI
00816036029089
Brand
STATSWABII®
Company
MICRO DISTRIBUTING, L.C
Model
SWABII-158
Catalog number
SWABII-158
Device description
STATSWABII saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/THC
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVDTest, Methamphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816036028587PrimaryGS10
00816036029089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816036028587008160360285878160360285870816036028587
00816036029089008160360290898160360290890816036029089

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
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
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPVD2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPVD2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PVD2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PVD2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPVD2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PVD2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PVD2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPVD2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPVD2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PVD2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPVD2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPVD2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PVD2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPVD2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PVD2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPVD2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPVD2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPVD2024-09-29