FDA.reportPublic FDA data

wtATTR-CM AcceleraTTR™

Primary DI
05415062388310
Brand
wtATTR-CM AcceleraTTR™
Company
PFIZER INC.
Model
CI4054279
Device description
Software to identify heart failure patients who may be at risk of having wtATTR-CM
Published
2022-07-29
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
JQPCalculator/data processing module, for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415062388310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415062388310054150623883105415062388310

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(484)865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
829076566
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00305733010020ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010037ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010075ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010389ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010396ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010969ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733010983ThermaCare HeatWrapsThermaCare HeatWraps - Lower Back & Hip2020-05-29
00305733013014ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013038ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733013144ThermaCare HeatWrapsThermaCare HeatWraps - Muscle & Joint2020-05-29
00305733015025ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015353ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015445ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015957ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733015971ThermaCare HeatWrapsThermaCare HeatWraps - Neck, Wrist & Shoulder2020-05-29
00305733017241ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
00305733017258ThermaCare HeatWrapsThermaCare HeatWraps - Flexible2020-05-29
00305733020029ThermaCare HeatWrapsThermaCare HeatWraps - Menstrual2020-05-29
00305733020449ThermaCare HeatWrapsThermaCare HeatWraps - Menstrual2020-05-29
00305733040010ThermaCare ColdWrapsThermaCare ColdWraps2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374187SoftPathSCC SOFT COMPUTERJQP2026-11-05
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00810142374668SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-28
00810142374675SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-28
00810142374682SoftPathDxSCC SOFT COMPUTERJQP2026-10-28
00810142374699SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-28
00810142374705SoftHLASCC SOFT COMPUTERJQP2026-10-28
00810142374712SoftMolecularSCC SOFT COMPUTERJQP2026-10-28
00810142374729SoftGenomicsSCC SOFT COMPUTERJQP2026-10-28
00810142374736SoftTrackSCC SOFT COMPUTERJQP2026-10-28
00810142374941SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-16
00810142374958SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-16
00810142374965SoftPathDxSCC SOFT COMPUTERJQP2026-10-16
00810142374972SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-16
00810142374989SoftHLASCC SOFT COMPUTERJQP2026-10-16
00810142374996SoftMolecularSCC SOFT COMPUTERJQP2026-10-16
00810142375009SoftGenomicsSCC SOFT COMPUTERJQP2026-10-16
00810142375016SoftTrackSCC SOFT COMPUTERJQP2026-10-16
00810142374071SoftTotalQCSCC SOFT COMPUTERJQP2026-10-07
00810142373456SoftLabSCC SOFT COMPUTERJQP2026-09-29
00810142373463SoftMicSCC SOFT COMPUTERJQP2026-09-29
B236CATL202520Clinisys AtlasCliniSys, IncJQP2026-09-29
00380740225384AlinIQABBOTT SRLJQP2026-09-28
00810142374378SoftBiochemistrySCC SOFT COMPUTERJQP2026-08-26
00810142374385SoftCytogeneticsSCC SOFT COMPUTERJQP2026-08-26
00810142374392SoftPathDxSCC SOFT COMPUTERJQP2026-08-26
00810142374408SoftFlowCytometrySCC SOFT COMPUTERJQP2026-08-26
00810142374415SoftHLASCC SOFT COMPUTERJQP2026-08-26
00810142374422SoftMolecularSCC SOFT COMPUTERJQP2026-08-26
00810142374439SoftGenomicsSCC SOFT COMPUTERJQP2026-08-26