FDA.reportPublic FDA data

NOVEOS Kentucky Blue Grass, Poa pratensis

Primary DI
00816879029307
Brand
NOVEOS Kentucky Blue Grass, Poa pratensis
Company
HYCOR BIOMEDICAL LLC
Model
G008
Catalog number
8632850Z
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
00816879029307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879029307008168790293078168790293070816879029307

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
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
00816879029376NOVEOS Maple Leaf Sycamore, London Plane, Platanus acerifoliaHYCOR 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