FDA.reportPublic FDA data

UP20 Positive Control Reagent

Primary DI
00813382010280
Brand
UP20 Positive Control Reagent
Company
Minaris Medical America, Inc.
Model
80107
Catalog number
80107
Device description
UP20 Positive Control Reagent
Published
2017-06-15
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
DGCIGE, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051677000OPTIGEN ALLERGEN SPECIFIC IGE ASSAYHitachi Chemical Diagnostics, Inc.2006-01-23DHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813382010280PrimaryGS10
00813382010341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813382010280008133820102808133820102800813382010280
00813382010341008133820103418133820103410813382010341

GMDN Terms#

Term, Definition table
TermDefinition
Multiple allergen-specific/total immunoglobulin E (IgE) antibody IVD, controlA material which is used to verify the performance of an assay intended to be 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 Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)961-5501info@hcdiagnostics.com

Regulatory Flags#

DUNS number
102113867
Device count
3
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813382010013OPTIGEN® Allergen-Specific IgE Assay - Food 29 (20T)85067850672022-04-27
00813382010020OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND)85267852672022-04-27
00813382010037OPTIGEN® Allergen-Specific IgE Assay - Environmental 36 (20T)85068850682022-04-27
00813382012154OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (40ND)85167851672022-04-27
00813382012178OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (40ND)85168851682022-04-27
00813382012185OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36 (100ND)85268852682022-04-27
00813382010426OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND)85081850812019-05-22
00813382010433OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)85082850822019-05-22
00813382010440OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)85066850662019-05-22
00813382010006OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel85003850032017-01-16
00813382010075OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel85003850032016-08-19
00813382010105CLA® Allergen-Specific IgE Assay - Eastern84502845022016-08-19
00813382010112CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel84504845042016-08-19
00813382010129CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel84505845052016-08-19
00813382010136CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel84506845062016-08-19
00813382010143CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel84507845072016-08-19
00813382010150CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel84509845092016-08-19
00813382010167CLA® Allergen-Specific IgE Assay - Western Inhalant Panel84511845112016-08-19
00813382010174CLA® Allergen-Specific IgE Assay - Moderate Food Panel84518845182016-08-19
00813382010334CLA® Allergen-Specific IgE Assay - Eastern84508845082016-09-12

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