FDA.reportPublic FDA data

Tanner Scientific®

Primary DI
00850011007143
Brand
Tanner Scientific®
Company
MERCEDES MEDICAL, LLC
Model
TNR 10SG
Catalog number
TNR 10SG
Device description
Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
CENDye-Indicator, Ph (Urinary, Non-Quant.)
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
JINNitroprusside, Ketones (Urinary, Non-Quant.)
JIOBlood, Occult, Colorimetric, In Urine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111999000HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLC2012-04-17JIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850011007140PackageGS1100In Commercial Distribution
20850011007147PackageGS11In Commercial Distribution
00850011007143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001100714010850011007140
2085001100714720850011007147
00850011007143008500110071438500110071430850011007143

GMDN Terms#

Term, Definition table
TermDefinition
Urine glucose IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for glucose within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick 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 Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Do not remove desiccants in the bottles.
Special Storage Condition, Specify00Keep away from direct sunlight, and moisture.
Special Storage Condition, Specify00Strips must be kept in the original bottle, or it may shorten the expiration date of product.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
834472680
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
00850011007112BluRapids™TNR CDOA7125A3TNR CDOA7125A32016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03