FDA.reportPublic FDA data

ACE

Primary DI
00857969006440
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
RX1010
Catalog number
RX1010
Device description
Cholesterol 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
CHHEnzymatic Esterase--Oxidase, Cholesterol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical 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
00857969006440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006440008579690064408579690064400857969006440

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid 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 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
9738520158HKatz@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.CHH2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.CHH2026-06-03
00816042016387FORAFORA CARE INC.CHH2026-04-27
00850014861834heartscare Total Cholesterol Test Strip (10pcs/box)Hearts Bio, Inc.CHH2026-04-17
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TAcon Laboratories, Inc.CHH2026-03-09
00682607690077Mission Cholesterol Optical Check DeviceAcon Laboratories, Inc.CHH2026-03-09
00682607690084Mission Cholesterol Control SolutionAcon Laboratories, Inc.CHH2026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
00682607690060Mission Cholesterol MeterAcon Laboratories, Inc.CHH2026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
04719893233834XPER Technology Procheck Witty Procheck Smart Total Cholesterol Test StripsTAIDOC TECHNOLOGY CORPORATIONCHH2025-10-30
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-07-02
00381934770017CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
10381934770014CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
00380740158125AlinityABBOTT IRELANDCHH2025-04-15
00380740158132ARCHITECTABBOTT IRELANDCHH2025-04-15
00380740158149ARCHITECTABBOTT IRELANDCHH2025-04-15
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.CHH2025-03-31
00816042015205FORAFORA CARE INC.CHH2025-03-14
80816042015201FORAFORA CARE INC.CHH2025-03-14
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.CHH2024-07-12
08806141303701Newfoundland Cholesterol TestDFI CO.,LTDCHH2024-05-29
00850053916083IDG/SanzayIDG/SANZAY CorporationCHH2024-01-09
00893038002883Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002890Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002906Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002913Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20
00893038002920Cholestech LDX™Alere San Diego, Inc.CHH2023-12-20