FDA.reportPublic FDA data

ACE

Primary DI
00857969006570
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
SA2016
Catalog number
SA2016
Device description
Inorganic Phosphorus U.V. Reagent
Published
2017-10-10
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
K113374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113374000ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-07-13CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006570008579690065708579690065700857969006570

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) 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 inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-852-0158HKatz@alfawassermannUS.com

Regulatory Flags#

DUNS number
781990924
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
00857969006136ACESA2001SA20012016-09-24
00857969006068ACERX1012RX10122016-09-24
00857969006112ACESA1012SA10122016-09-24
00857969006433Alfa WassermannC2-87C2-872017-10-10
00857969006693ACE Alera®402900-1402900-12021-01-07
00857969006709ACE Axcel®404200-1404200-12021-01-07
00857969006181Alfa WassermannS1-33S1-332016-09-24
00857969006198Alfa WassermannS2-85S2-852016-09-24
00857969006396Alfa WassermannC1-42017-07-25
00857969006402Alfa WassermannC1-5C1-52017-07-25
00857969006662ACESA1052SA10522020-07-01
00857969006679ACESA1053SA10532020-07-01
00857969006686ACERX1053RX10532020-07-01
00857969006624ACESA1020SA10202020-04-09
00857969006631ACESA1021SA10212020-04-09
00857969006648ACESA1027SA10272020-04-09
00857969006655ACESA1028SA10282020-04-09
00857969006600Alfa WassermannS2-87S2-872020-04-03
00857969006617ACESA1050SA10502020-04-03
00857969006020ACEACI-32ACI-322017-10-10

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