FDA.reportPublic FDA data

ACE

Primary DI
00857969006471
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
RX1026
Catalog number
RX1026
Device description
LDL-C 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
MRRSystem, Test, Low Density, Lipoprotein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113262000ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-07-03CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006471008579690064718579690064710857969006471

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid 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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
10673486002010Teco Diagnostics Direct LDL Cholesterol Reagent SetTECO DIAGNOSTICSMRR2023-11-13
06971674860587BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860594BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860600BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860617BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860624BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860631BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860648BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860655BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860662BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860679BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860686BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860693BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860709BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860716BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860723BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860730BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860747BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860754BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860761BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
05055273213966DIRECT LDL-CHOLESTEROL (LDL)RANDOX LABORATORIES LIMITEDMRR2022-10-04
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024487CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024623CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00630414611037Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
00630414305073Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08