FDA.reportPublic FDA data

Alfa Wassermann

Primary DI
00857969006600
Brand
Alfa Wassermann
Company
ALFA WASSERMANN, INC.
Model
S2-87
Catalog number
S2-87
Device description
Hemoglobin A1c Calibrators
Published
2020-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063306000ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72Alfa Wassermann, Inc.2007-04-17LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006600008579690066008579690066000857969006600

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement 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
00857969006617ACESA1050SA10502020-04-03
00857969006020ACEACI-32ACI-322017-10-10
00857969006419ACEC2-85C2-852017-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10758750035373VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
20758750035370VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-05-20
05051700020534Optilite® Low Level Total Protein CalibratorTHE BINDING SITE GROUP LIMITEDJIS2024-10-30
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAMIYA BIOMEDICAL COMPANY, LLCJIS2024-04-17
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414313450Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIS2024-04-03
00630414639833INNOVANCE Heparin CalibratorSiemens Healthcare Diagnostics Products GmbHJIS2024-03-25
15099590752699Access Progesterone II CalibratorsBeckman Coulter, Inc.JIS2024-03-01
00630414611297Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414636672Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414305141Atellica CH RCRP CalSiemens Healthcare Diagnostics Inc.JIS2024-02-02
00630414313467Atellica CH Protein 1 Calibrator (PROT 1 CAL)Siemens Healthcare Diagnostics Inc.JIS2024-02-02
10758750034635VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
20758750034632VITROSORTHO CLINICAL DIAGNOSTICSJIS2024-01-20
00380740197636AlinityAbbott GmbHJIS2023-11-04
07613336203538Anti-Tg CalSetRoche Diagnostics GmbHJIS2023-10-31
07613336175088CalSet FT4 IVRoche Diagnostics GmbHJIS2023-05-02
10758750033799VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
10758750033850VITROSORTHO CLINICAL DIAGNOSTICSJIS2023-03-28
03607360047606CDT CAPILLARYS CALIBRATORS (2 Levels)SEBIAJIS2022-12-12
03607360047613CDT MINICAP CALIBRATORS ( 2 Levels)SEBIAJIS2022-12-12
10758750034642VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-26
10758750034659VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
10758750034895VITROSORTHO CLINICAL DIAGNOSTICSJIS2022-10-24
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDJIS2022-10-05
00817302024340CAROLINA LIQUID CHEMISTRIES CORP.® IRON STANDARD (FESTD) CC618-STDCAROLINA LIQUID CHEMISTRIES CORPORATIONJIS2022-08-19
00630414610863Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08
00630414305165Atellica CH HDLC CALSiemens Healthcare Diagnostics Inc.JIS2022-07-08