FDA.reportPublic FDA data

QuanTtest Red Pyrogallol Red Reagent

Primary DI
00896863002349
Brand
QuanTtest Red Pyrogallol Red Reagent
Company
QUANTIMETRIX CORPORATION
Model
5210-12
Catalog number
5210-12
Device description
QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.
Published
2019-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K904603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904603000QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEMQuantitative Medicine, Inc.1991-01-25CEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M0515210120PreviousHIBCC0
00896863002349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896863002349008968630023498968630023490896863002349

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
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(310) 536-0006sales@quantimetrix.com

Regulatory Flags#

DUNS number
010717890
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)1540-031540-032023-05-04
00896863002356QuanTtest Human Protein Standards Set3410-023410-022021-09-10
00896863002004Dropper Spinal Fluid Control Level 1 Set 3x3mL1451-311451-312018-09-26
00896863002011Dropper Spinal Fluid Control Level 2 Set 3x3mL1452-311452-312018-09-26
00896863002073Dropper Spinal Fluid Control Level 1&2 Set 2x3mL1450-011450-012018-09-26
00896863002042Chromascopics Control Level 1&2 Set 4x120mL (Domestic)1540-021540-022018-09-26
00896863002066Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL1510-021510-022018-09-26
00896863002394Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL1470-021470-022019-03-13
00896863002028Sweat Control Level 1, 2, & 3 Set 9x3mL1190-011190-012018-09-26
00896863002035Chromascopics Control Level 1&2 Set 4x120mL (International)1540-011540-012018-09-26
00896863002059Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL1290-011290-012018-09-26
00896863002080Spinalscopics Control Level 1 Set 3x3mL1461-311461-312018-09-26
00896863002097Spinalscopics Control Level 2 Set 3x3mL1462-311462-312018-09-26
00896863002103Microbumin Microalbumin Control Level 1&2 Set 10x7mL1250-011250-012018-09-26
00896863002110Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL1440-021440-022018-09-26
00896863002127Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL1440-031440-032018-09-26
00896863002134Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL1440-011440-012018-09-26
00896863002141Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL1442-611442-612018-09-26
00896863002158Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL1440-041440-042018-09-26
00896863002165Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL1440-061440-062018-09-26

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