FDA.reportPublic FDA data

Tanner Scientific®

Primary DI
20850011007123
Brand
Tanner Scientific®
Company
MERCEDES MEDICAL, LLC
Model
TNR DOA12A
Catalog number
TNR DOA12A
Device description
Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/THC
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153050000Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.2016-04-26DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850011007126PackageGS125In Commercial Distribution
20850011007123PackageGS14In Commercial Distribution
00850011007129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001100712610850011007126
2085001100712320850011007123
00850011007129008500110071298500110071290850011007129

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid 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 cannabinoids 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Keep away from direct sunlight, moisture, and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003312716sherry.harris@mercedesmedical.com

Regulatory Flags#

DUNS number
834472680
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00850011007228BluWingMER 1921MER 19212017-07-01
00850011007235BluWingMER 1923MER 19232017-07-01
00850011007242BluWingMER 1925MER 19252017-07-01
00850011007143Tanner Scientific®TNR 10SGTNR 10SG2016-08-15
00850011007280BluRapidsTNR CDOA6125MTNR CDOA6125M2017-08-09
00850011007174Tanner Scientific®TNR HCGCOMBOTNR HCGCOMBO2016-08-22
00860008185136BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185112BluTouchTNR 700LTNR 700L2023-05-15
10860008185133BluTouchTNR 700XLTNR 700XL2023-05-15
00860008185105BluTouchTNR 700STNR 700S2022-12-28
00860008185129BluTouchTNR 700MTNR 700M2022-12-28
00850011007129Tanner Scientific®TNR DOA12ATNR DOA12A2016-08-15
00850011007136Tanner Scientific®TNR DOA13ATNR DOA13A2016-08-15
00850011007310Platinum+MER HCDOAY6125MER HCDOAY61252018-03-30
00850011007570Platinum+MER MMDOAY6125MER MMDOAY61252018-08-10
00850011007068BluRapids™TNR CDOA6125TNR CDOA61252016-08-15
00850011007075BluRapids™TNR CDOA5125A3TNR CDOA5125A32016-08-15
00850011007082BluRapids™TNR CDOA7125TNR CDOA71252016-08-15
00850011007099BluRapids™TNR MMC12MOPTNR MMC12MOP2016-08-15
00850011007105BluRapids™TNR CDOA2135TNR CDOA21352016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyLDJ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10722066008369Rapid ResponseBTNX IncLDJ2024-02-26
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncLDJ2023-04-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLDJ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLDJ2019-02-13