FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746014
Brand
Trinity Biotech
Company
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Model
305-10
Catalog number
305-10
Device description
ACE Reagent
Published
2016-09-23
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
KQNRadioassay, Angiotensin Converting Enzyme

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854245000SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVSigma Diagnostics, Inc.1986-01-22KQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746014053915167460145391516746014

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
+35312769800Clinicalchemistry.techsupport@
+35312769800Clinicalchemistry.techsupport@trinitybiotech.com

Regulatory Flags#

DUNS number
988298840
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516741927Trinity Biotech450-A450-A2016-09-23
05391516742238Trinity Biotech591-C591-C2017-10-06
05391516742245Trinity Biotech591-D 591-D 2017-10-06
05391516746106Uni-Gold™ 120650612065062016-09-23
05391516746113Uni-Gold™ 120653012065302016-09-23
05391516742290Trinity Biotech 826-10826-102016-09-23
05391516745161Bartels®B1029-81AB1029-81A2016-09-23
05391516745826Bartels®B1029-44B1029-442016-09-23
05391516745864Bartels® B1029-44CB1029-44C2016-09-23
05391516745871Bartels®B1029-81B1029-812016-09-23
05391516745888Bartels®B1029-81BB1029-81B2016-09-23
05391516745901Bartels®B1029-91B1029-912016-09-23
05391516745918Bartels®B1029-47B1029-472016-09-23
05391516745925Bartels®B1029-47CB1029-47C2016-09-23
05391516745932Bartels®B1029-48B1029-482016-09-23
05391516745949Bartels® B1029-47BB1029-47B2016-09-23
05391516746007MicroTrak®8H219UL8H219UL2016-09-23
05391516746038MicroTrak®8H349UL 8H349UL 2016-09-23
05391516746144MicroTrak®8H399UL8H399UL2016-09-23
05391516748643MicroTrak®8H329UL8H329UL2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EBUHKKACK20BÜHLMANN ACE KineticBühlmann Laboratories AGKQN2025-06-27
08058056685308ACE ReagentSENTINEL CH. SPAKQN2025-01-27
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
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