FDA.reportPublic FDA data

K-ASSAY® Total IgE Reagent

Primary DI
00816426020375
Brand
K-ASSAY® Total IgE Reagent
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-092
Catalog number
KAI-092
Device description
For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DGCIge, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DGCIge, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042241000K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CKamiya Biomedical Co.2004-12-10DGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020375008164260203758164260203750816426020375

GMDN Terms#

Term, Definition table
TermDefinition
Multiple allergen-specific/total immunoglobulin E (IgE) antibody 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 measurement of immunoglobulin E (IgE) antibodies to multiple specific protein allergens and/or total immunoglobulin E (IgE total) 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
206-575-8068diagnostics@k-assay.com

Regulatory Flags#

DUNS number
197934250
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816426020894K-ASSAY® Plasma ControlK81C-6MK81C-6M2016-09-16
00816426020924K-ASSAY® Coagulation ControlK104C-10MK104C-10M2016-09-16
00816426021013K-ASSAY® Coagulation ControlK204C-10MK204C-10M2016-09-16
00816426021099K-ASSAY® Factor XIII ControlK135C-10MK135C-10M2017-02-09
00816426021129K-ASSAY® Factor XIII ControlK204C-10MK204C-10M2017-02-09
00816426021266K-ASSAY® D-Dimer ControlK92C-2MK92C-2M2018-05-30
00816426021273K-ASSAY® D-Dimer ControlK92C-4MK92C-4M2018-05-30
00816426021600K-ASSAY® Cystatin C CalibratorKAI-200CKAI-200C2026-04-16
00816426021617K-ASSAY® Cystatin C ControlK200C-2MK200C-2M2026-04-16
00816426021594K-ASSAY® UIBC ReagentKAI-305KAI-3052026-03-13
00816426021549K-ASSAY® CRP Reagent (Ver.2)KAI-375KAI-3752026-02-27
00816426021556K-ASSAY® CRP Calibrator (Ver.2)KAI-376CKAI-376C2026-02-27
00816426020146K-ASSAY® Alpha-1 AG ReagentKAI-021KAI-0212016-09-16
00816426020672K-ASSAY® Total IgE CalibratorKAI-093CKAI-093C2016-09-16
00816426021389K-ASSAY® Total IgE ControlK94C-4MK94C-4M2019-01-25
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAI-400CKAI-400C2024-04-17
00816426020641K-ASSAY® CRP (3) Calibrator FKAI-086CKAI-086C2016-09-16
00816426020269K-ASSAY® Fructosamine Reagent + Calibrator (L)KAI-050KAI-0502016-09-16
00816426021402K-ASSAY® UIBC Reagent (L)KAI-301KAI-3012019-04-09
00816426020177K-ASSAY® Apo B Reagent (L)KAI-024KAI-0242016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024400IgE-XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2024-09-13
00850054026477QMedix™Diagnostic Automation, Inc.DGC2024-01-31
00380740153700AlinityABBOTT LABORATORIESDGC2023-10-14
04048474017885Immunoglobulin E (IgE) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDGC2023-08-26
15099590701727Total Immunoglobulin E (IgE)Beckman Coulter, Inc.DGC2022-05-03
00840239017888Immunoglobulin E (IgE) ELISADRG International IncDGC2021-06-07
00380740156282ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156367ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156404ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00850392007350BioCheck IgE EIA Test KitBIOCHECK, INC.DGC2019-10-08
07333066019864ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066000664ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066019772ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066019789ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066019796ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066000206ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066000220ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066000367ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066019512ImmunoCAP Total IgE CalibratorsPhadia ABDGC2019-03-26
07333066019529ImmunoCAP Total IgE Curve ControlsPhadia ABDGC2019-03-26
07333066019642ImmunoCAP Total IgE Control LMHPhadia ABDGC2019-03-26
07333066019673ImmunoCAP Total IgEPhadia ABDGC2019-03-26
00816870020242IgE AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870020259Monobind AccuBind IgE ELISA Kit - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870020266IgE AccuBind ELISA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870020273IgE AccuBind ELISA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11
00816870021928Monobind AccuLite IgE CLIA Kit - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870021935IgE AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870021942IgE AccuLite CLIA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870021959IgE AccuLite CLIA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11