FDA.reportPublic FDA data

ACE

Primary DI
00857969006211
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
S3-4
Catalog number
S3-4
Device description
T4 Calibrators
Published
2016-09-24
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
JISCalibrator, Primary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006211008579690062118579690062110857969006211

GMDN Terms#

Term, Definition table
TermDefinition
Total thyroxine (TT4) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of total thyroxine (TT4) 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
07613336172841CalSet DHEA-S IIRoche Diagnostics GmbHJIS2026-08-07
10758750033539VITROSORTHO CLINICAL DIAGNOSTICSJIS2025-12-30
15099590754495Access Total T4 II CalibratorsBeckman Coulter, Inc.JIS2025-09-19
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