FDA.reportPublic FDA data

ACE

Primary DI
00857969006617
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
SA1050
Catalog number
SA1050
Device description
Hemoglobin A1c Reagent
Published
2020-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170623000ACE Hemoglobin A1c (HbA1c) ReagentAlfa Wassermann Diagnostic Technologies, LLC2018-02-27LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006617008579690066178579690066170857969006617

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) 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 qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin 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
973-852-0178AGennis@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
00857969006020ACEACI-32ACI-322017-10-10
00857969006419ACEC2-85C2-852017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26
05391516749893Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749909Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749916Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749923Trinity BiotechPRIMUS CORPORATIONLCP2024-04-12
05391516749930Trinity Biotech PRIMUS CORPORATIONLCP2024-04-12
10304040178437Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
00304040178430Henry ScheinHENRY SCHEIN, INC.LCP2024-01-12
10673486001792Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent SetTECO DIAGNOSTICSLCP2023-11-15
10673486001808Teco Diagnostics Hemoglobin A1c Set for TC Matrix SystemsTECO DIAGNOSTICSLCP2023-11-10
00381933080018A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
10381933080015A1CNow Self Check, 8ct.POLYMER TECHNOLOGY SYSTEMS, INC.LCP2023-10-25
03661540304286Direct A1c Control KitELITECHGROUP INC.LCP2023-10-01
03661540304293Direct A1c Calibrator KitELITECHGROUP INC.LCP2023-10-01