Sepsis ImmunoScore

Primary DI
00860013516208
Brand
Sepsis ImmunoScore
Company
Prenosis, Inc.
Model
1.6.0
Published
2025-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
SAKSoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAKSoftware Device To Aid In The Prediction Or Diagnosis Of SepsisGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230036000Sepsis ImmunoScorePrenosis, Inc.2024-04-02SAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013516208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013516208008600135162088600135162080860013516208

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support software IVDAn in vitro diagnostic application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic, laboratory results, genomic data) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, suggested therapy/pharmaceutical dosage) to a healthcare professional responsible for patient care. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app. It is not primarily intended to manage diagnostic/patient images.

Contacts#

Phone, Email table
PhoneEmail
(312) 235-3580madison.green@prenosis.com

Regulatory Flags#

DUNS number
079414131
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false