FDA.reportPublic FDA data

OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel

Primary DI
00813382010006
Brand
OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel
Company
Minaris Medical America, Inc.
Model
85003
Catalog number
85003
Device description
KIT, OPTIGEN Universal Panel 20
Published
2017-01-16
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
DHBSYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalImmunology2

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
00813382010006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813382010006008133820100068133820100060813382010006

GMDN Terms#

Term, Definition table
TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an allergen-specific immunoglobulin E (IgE) antibody in a clinical specimen, using a chemiluminescent immunoassay method.

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
1
DM exempt
true
Kit
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
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
00813382010372OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel85063850632017-10-09

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