FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021903
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
PHO2-BUL
Device description
PHOSPHORUS BULK LIQUID (in 20L Cubitainers
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003912000PHOSPHORUS REAGENTJas Diagnostics, Inc.2001-02-21CEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021903008172740219038172740219030817274021903

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-305-324-2300customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020715JAS DiagnosticsALP2-120R1U2016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155643AlinityABBOTT IRELANDCEO2024-03-11
00380740155650AlinityABBOTT IRELANDCEO2024-03-11
00380740155629ARCHITECTABBOTT IRELANDCEO2024-02-26
00380740155636ARCHITECTABBOTT IRELANDCEO2024-02-26
00850053916120IDG/SanzayIDG/SANZAY CorporationCEO2024-01-12
10673486001976Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC MatrixTECO DIAGNOSTICSCEO2023-11-13
10673486001945Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method)TECO DIAGNOSTICSCEO2023-11-10
10673486001969Teco Diagnostics Inorganic Phosphorus Reagent Set (UV Method)TECO DIAGNOSTICSCEO2023-11-10
06971674865056BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865070BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865087BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865100BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865117BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865124BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865131BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865148BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865155BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865032BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865049BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865063BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865094BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
05055273204865INORGANIC PHOSPHOROUS (PHOS)RANDOX LABORATORIES LIMITEDCEO2022-10-05
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024272CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT CC218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024432CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT DT218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024579CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT ST218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024098CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT AU-218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-07-06
04015630918973Phosphate (Inorganic) ver.2Roche Diagnostics GmbHCEO2021-05-27
04015630927265Phosphate ver.2Roche Diagnostics GmbHCEO2021-02-08
00811727015945Pointe Phosphorus ReagentHORIBA INSTRUMENTS INCORPORATEDCEO2021-01-30