FDA.reportPublic FDA data

ACE Reagent

Primary DI
08058056685308
Brand
ACE Reagent
Company
SENTINEL CH. SPA
Model
06U8225
Catalog number
06U8225
Device description
The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the ARCHITECT c System.This test is used as an aid in the diagnosis of pulmonary sarcoidosis and other pathologic conditions involving lung and liver diseases.For laboratory professional use only.
Published
2025-01-27
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
KQNRadioassay, Angiotensin Converting Enzyme

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQNRadioassay, Angiotensin Converting EnzymeClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056685308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056685308080580566853088058056685308

GMDN Terms#

Term, Definition table
TermDefinition
Angiotensin converting enzyme (ACE) 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 angiotensin converting enzyme (ACE) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680181Ammonia Ultra 17660176602023-11-22
08058056680617Lipase Color Liquid17401B17401B2017-01-16
08058056681911CRP Ultra (MP)1156461156462018-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EBUHKKACK20BÜHLMANN ACE KineticBühlmann Laboratories AGKQN2025-06-27
08058056685339ACE ReagentSENTINEL CH. SPAKQN2025-01-27
06971674866831BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866848BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674866855BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674867852BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
06971674868361BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KQN2023-07-22
05391516746014Trinity BiotechTRINITY BIOTECH PUBLIC LIMITED COMPANYKQN2016-09-23
EBUHKKACK1ACE Kinetik KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACK21ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACK41ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
EBUHKKACKX1ACE Kinetic KitBühlmann Laboratories AGKQN2016-09-01
08058056681751ACE LiquidSENTINEL CH. SPAKQN2016-07-29