FDA.reportPublic FDA data

MedTest DX Total Protein for the BS480

Primary DI
00817439021281
Brand
MedTest DX Total Protein for the BS480
Company
Medtest Dx, Inc.
Model
TP480
Catalog number
TP480
Device description
For the quantitative determination of total protein concentration in serum using the Mindray BS-480 analyzer. 8 x 60ml.
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEKBiuret (Colorimetric), Total Protein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEKBiuret (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822468000PSI TOTAL PROTEIN REAGENTPointe Scientific, Inc.,1982-09-14CEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817439021281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817439021281008174390212818174390212810817439021281

GMDN Terms#

Term, Definition table
TermDefinition
Total protein IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total protein in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
070371210
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817439020000Direct Lipid Control Set300030002016-09-27
00817439020017Direct Lipid Control L1300130012016-09-27
00817439020024Direct Lipid Control L2300230022016-09-27
00817439020031Direct Lipid Control L3300330032016-09-27
00817439020062Wash Concentrate 103W50003W5002016-09-27
00817439020079Wash Concentrate 209W50009W5002016-09-27
00817439020086Wash Concentrate 310W50010W5002016-09-27
00817439020093Albumin / BS480ALB480ALB4802016-09-27
00817439020109AlbuminALB505ALB5052016-09-27
00817439020116Albumin / BS200ALB600ALB6002016-09-27
00817439020123Alkaline Phos/ BS480ALP480ALP4802016-09-27
00817439020130ALP ReagentALP505ALP5052016-09-27
00817439020147MedTest DX Alkaline PhosphataseALP600ALP6002016-09-27
00817439020192Amylase / BS480AMY480AMY4802016-09-27
00817439020215Amylase / BS200AMY600AMY6002016-09-27
00817439020222AST / BS480AST480AST4802016-09-27
00817439020239AST / Polychem 180AST505AST5052016-09-27
00817439020246AST / BS200AST600AST6002016-09-27
00817439020314C1 Cleaning SolutionC1S500C1S5002016-09-27
00817439020321Calibrator Level 1 CA1100CA11002016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654010Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2026-03-18
00850053916144IDG/SanzayIDG/SANZAY CorporationCEK2024-01-12
00630414611082Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
00630414306025Atellica CH Total Protein_2Siemens Healthcare Diagnostics Inc.CEK2023-12-13
10673486002171Teco Diagnostics CSF/Urine Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002201Teco Diagnostics Total Protein Reagent SetTECO DIAGNOSTICSCEK2023-11-14
10673486002218Teco Diagnostics Total Protein Reagent Kit for TC-MatrixTECO DIAGNOSTICSCEK2023-11-14
06971674862215BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862222BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862239BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862246BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862253BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862260BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862277BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862284BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862291BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862307BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862314BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862321BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862338BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862352BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862369BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862376BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
06971674862383BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEK2023-07-21
05055273206531TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206555TOTAL PROTEIN (TP)RANDOX LABORATORIES LIMITEDCEK2022-10-05
05055273206562TOTAL PROTEIN 2 (TP 2)RANDOX LABORATORIES LIMITEDCEK2022-10-05
00380740155469ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155476ARCHITECTABBOTT IRELANDCEK2022-07-12
00380740155261AlinityABBOTT IRELANDCEK2022-06-30