FDA.reportPublic FDA data

ProNephro AKI™ (NGAL) Calibrator Kit

Primary DI
05711435000255
Brand
ProNephro AKI™ (NGAL) Calibrator Kit
Company
Bioporto Diagnostics A/S
Model
ST102UA
Published
2024-08-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIGAcute Kidney Injury Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIGAcute Kidney Injury Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232761000ProNephro AKI™ (NGAL)Bioporto Diagnostic, Inc.2023-12-07PIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711435000255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711435000255057114350002555711435000255

GMDN Terms#

Term, Definition table
TermDefinition
Neutrophil gelatinase-associated lipocalin (NGAL) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of neutrophil gelatinase-associated lipocalin (NGAL) in a clinical specimen.

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
+4545290000ra@bioporto.com

Regulatory Flags#

DUNS number
586925158
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711435000156ProNephro AKI™ (NGAL) Reagent KitST101UB087871741902025-08-28
05711435000163ProNephro AKI™ (NGAL) Calibrator KitST102UA087872041902025-08-28
05711435000170ProNephro AKI™ (NGAL) Control KitST103UA087872121902025-08-28
05711435000248ProNephro AKI™ (NGAL) Reagent Kit ST101UB2024-08-02
05711435000262ProNephro AKI™ (NGAL) Control KitST103UA2024-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711435000156ProNephro AKI™ (NGAL) Reagent KitBioporto Diagnostics A/SPIG2025-08-28
05711435000248ProNephro AKI™ (NGAL) Reagent Kit Bioporto Diagnostics A/SPIG2024-08-02
05711435000262ProNephro AKI™ (NGAL) Control KitBioporto Diagnostics A/SPIG2024-08-02
03573026616038VIDAS® NEPHROCHECK®BIOMERIEUX SAPIG2023-03-13
B0744000160ASTUTE140 Electronic Quality Control (EQC) DeviceBIOMERIEUX SAPIG2016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) KitBIOMERIEUX SAPIG2016-08-12
B0745000110NEPHROCHECK Test Kit BIOMERIEUX SAPIG2016-08-12
B0745000130NEPHROCHECK Liquid Control KitBIOMERIEUX SAPIG2016-08-12
B0745000170ASTUTE140 Meter KitBIOMERIEUX SAPIG2016-08-12