FDA.reportPublic FDA data

NOVEOS Maple Leaf Sycamore, London Plane, Platanus acerifolia

Primary DI
00816879029376
Brand
NOVEOS Maple Leaf Sycamore, London Plane, Platanus acerifolia
Company
HYCOR BIOMEDICAL LLC
Model
T011
Catalog number
8633540Z
Published
2025-05-12
Public version status
New
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
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt AllergensImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879029376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879029376008168790293768168790293760816879029376

GMDN Terms#

Term, Definition table
TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaF0188632330Z2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaF0368634210Z2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.F0408632420Z2026-05-29
00810053950227NOVEOS Salmon, Salmo salarF0418638910Z2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusF07563247Z2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisF2018633630Z2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraF2038632630Z2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisF2908633830Z2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaF01886323302026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.F04086324202026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraF20386326302026-05-29
00816879024548NOVEOS Salmon, Salmo salarF04186389102026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisF20186336302026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisF29086338302026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusF075632472026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
00816879020212Autostat II Anti-Nuclear Antibody (ANA) ScreenFGA212016-09-26
00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-3Z2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950524NOVEOS Cladosporium herbarumHYCOR BIOMEDICAL LLCPUW2026-01-12
00816879028393NOVEOS Cladosporium herbarumHYCOR BIOMEDICAL LLCPUW2026-01-12
00810053950609NOVEOS Virginia Live Oak, Quercus virginianaHYCOR BIOMEDICAL LLCPUW2025-10-03
00816879024128NOVEOS Virginia Live Oak, Quercus virginianaHYCOR BIOMEDICAL LLCPUW2025-10-03
00810053950586NOVEOS Mulberry, Morus albaHYCOR BIOMEDICAL LLCPUW2025-08-27
00816879024500NOVEOS Mulberry, Morus albaHYCOR BIOMEDICAL LLCPUW2025-08-27
00810053950623NOVEOS Lamb's Quarters, Goosefoot, Chenopodium albumHYCOR BIOMEDICAL LLCPUW2025-08-25
00816879024159NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium albumHYCOR BIOMEDICAL LLCPUW2025-08-25
00810053950180NOVEOS Carrot, Daucus carotaHYCOR BIOMEDICAL LLCPUW2025-08-21
00816879024630NOVEOS Carrot, Daucus carotaHYCOR BIOMEDICAL LLCPUW2025-08-21
00816879029956NOVEOS Sweet Vernal Grass, Anthoxanthum odoratumHYCOR BIOMEDICAL LLCPUW2025-06-30
00816879029963NOVEOS House Dust - GreerHYCOR BIOMEDICAL LLCPUW2025-06-30
00816879025026NOVEOS House Dust - GreerHYCOR BIOMEDICAL LLCPUW2025-06-25
00816879023916NOVEOS Sweet Vernal Grass, Anthoxanthum odoratumHYCOR BIOMEDICAL LLCPUW2025-05-30
00816879029277NOVEOS Meadow Fescue, Festuca elatiorHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029284NOVEOS Rye Grass, Lolium perenneHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029307NOVEOS Kentucky Blue Grass, Poa pratensisHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029314NOVEOS Bahia Grass, Paspalum notatumHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029338NOVEOS Gray Alder, Alnus incanaHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029345NOVEOS Mountain Juniper, Juniper sabinoidesHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029352NOVEOS Olive Tree, Olea europaeaHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029369NOVEOS Walnut, Juglans californicaHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029383NOVEOS Cottonwood Tree, Populus deltoidesHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029390NOVEOS White Ash, Fraxinus americanaHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029406NOVEOS Pecan, Hickory, Carya illinoinensisHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029413NOVEOS Mugwort, Artemisia douglasianaHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029420NOVEOS English Plantain, Plantago lanceolataHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029437NOVEOS Russian Thistle, Salsola kaliHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029444NOVEOS Common Pigweed, Amaranthus retroflexusHYCOR BIOMEDICAL LLCPUW2025-05-12
00816879029574NOVEOS Aspergillus fumigatusHYCOR BIOMEDICAL LLCPUW2025-05-12