FDA.reportPublic FDA data

OPTIGEN® Positive Control Reagent

Primary DI
00813382010082
Brand
OPTIGEN® Positive Control Reagent
Company
Minaris Medical America, Inc.
Model
82061
Catalog number
82061
Device description
OPTIGEN Positive Control
Published
2016-08-19
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
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
00813382010082PrimaryGS10
00813382010327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813382010082008133820100828133820100820813382010082
00813382010327008133820103278133820103270813382010327

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