FDA.reportPublic FDA data

ProtoFluor Calibrator - High (5 x 2.5 mL)

Primary DI
M52520110
Brand
ProtoFluor Calibrator - High (5 x 2.5 mL)
Company
HELENA LABORATORIES CORPORATION
Model
2011
Published
2017-03-17
Public version status
Update
Distribution status
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
JKJFLUOROMETRIC MEASUREMENT, PORPHYRINS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKJFluorometric Measurement, PorphyrinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893038000PROTOFLUOR ZHelena Laboratories1989-11-17JKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52520110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protoporphyrin IX 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 the porphyrin metabolite protoporphyrin IX in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
079396131
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M52551830AB-Trol 3 Coagulation Control51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)51852016-09-07
M52551860NORM-TROL 1 Coagulation Control51862016-09-07
M52551870AB-TROL 2 Coagulation Control51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)53022016-09-07
M52536110H-Pette without Blade (1000 pieces)36112017-05-26
M52536120H-Pette with Blade (1000 pieces)36122017-05-26
M52536130H-Pette Remover36132017-03-17
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)36152017-05-26
M52594230IFE Free Lambda Light Chain Antiserum94232024-09-27
M5255527370SPIFE Nexus IFE-6 Antisera Kit5527372024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera Kit5527442024-09-27
M52594190IFE IgD Antiserum94192024-09-27
M52594200IFE IgE Antiserum94202024-09-27
M52594220IFE Free Kappa Light Chain Antiserum94222024-09-27
M52520050000ProtoFluor Z (110V)20050002017-03-17
M52520050020ProtoFluor Z (110V)20050022017-03-17
M52520060000ProtoFluor Z (220V)20060002017-03-17
M52518360V8 Urine Preparation Buffer18362023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250317508713Reagent KitChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508744ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508768ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508805ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508829ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
04250317508843ReagentChromsystems Instruments + Chemicals GmbHJKJ2020-08-27
M52520010ProtoFluor Glass SlidesHELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520020ProtoFluor Reagent (2x15 mL)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520100ProtoFluor Calibrator - Low (5 x 2.5 mL)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M5255510560ProtoFluor Reagent System (Part 1 of 2)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M5255510570ProtoFluor Reagent System (Part 2 of 2)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520050000ProtoFluor Z (110V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520050020ProtoFluor Z (110V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17
M52520060000ProtoFluor Z (220V)HELENA LABORATORIES CORPORATIONJKJ2017-03-17