FDA.report

OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36

Primary DI
00813382010037
Brand
OPTIGEN® Allergen-Specific IgE Assay - US Environmental 36
Company
Minaris Medical America, Inc.
Model
85068
Catalog number
85068
Device description
KIT, OPTIGEN US Environmental 36
Published
2022-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

Product Code Classifications

CodeDeviceSpecialtyClass
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt AllergensImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813382010037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813382010037008133820100378133820100370813382010037

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
102113867
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00813382010013OPTIGEN® Allergen-Specific IgE Assay - US Food 3085067850672022-04-27
00813382010020OPTIGEN® Allergen-Specific IgE Assay - US Food 30 (100ND)85267852672022-04-27
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

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