FDA.reportPublic FDA data

OPTIGEN® AP 3600™ Automated Instrument

Primary DI
00813382010204
Brand
OPTIGEN® AP 3600™ Automated Instrument
Company
Minaris Medical America, Inc.
Model
95413
Catalog number
95413
Device description
Automated In Vitro Allergy Diagnostic System
Published
2019-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K182793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182793000AP3600 Automated InstrumentHitachi Chemical Diagnostics, Inc.2019-03-19DHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813382010204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813382010204008133820102048133820102040813382010204

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

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
Serial number
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
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCDHB2026-05-29
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00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCDHB2026-05-29
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00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCDHB2026-01-20
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00810053950500NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCDHB2026-01-20