FDA.reportPublic FDA data

ACE

Primary DI
00857969006266
Brand
ACE
Company
ALFA WASSERMANN, INC.
Model
SA2024
Catalog number
SA2024
Device description
BUN / UREA Reagent
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
CDNUrease, Photometric, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDNUrease, Photometric, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857969006266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857969006266008579690062668579690062660857969006266

GMDN Terms#

Term, Definition table
TermDefinition
Urea 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 urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.

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
10758750031788VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CDN2019-11-13
EABA40000061Piccolo General Chemistry 6ABAXIS, INC.CDN2016-09-23
EABA40000231Piccolo MetLyte 8 PanelABAXIS, INC.CDN2016-09-23
EABA40000241Piccolo Basic Metabolic PanelABAXIS, INC.CDN2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CDN2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CDN2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CDN2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CDN2016-09-23
EABA40000331Piccolo Kidney CheckABAXIS, INC.CDN2016-09-23
EABA40000341Piccolo MetLyte Plus CRPABAXIS, INC.CDN2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CDN2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CDN2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CDN2016-09-23
10758750004362VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CDN2016-08-23
10758750004973VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CDN2016-08-23
10758750004980VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CDN2016-08-23