FDA.reportPublic FDA data

NOVEOS Cladosporium herbarum

Primary DI
00816879028393
Brand
NOVEOS Cladosporium herbarum
Company
HYCOR BIOMEDICAL LLC
Model
M002
Catalog number
8632990
Published
2026-01-12
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
00816879028393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879028393008168790283938168790283930816879028393

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

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
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
00810053950388NOVEOS Gal d 2 Ovalbumin, EggF232C63265Z2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaF013632292026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkF076C632482026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggF232C632652026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-32026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonF0248632350Z2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaF2078633560Z2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraF2568632680Z2026-01-20
00810053950500NOVEOS German Cockroach, Blatella germanicaI0068632950Z2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonF02486323502026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaI00686329502026-01-20
00816879024555NOVEOS Clam, Mercenaria mercenariaF20786335602026-01-20
00816879028010NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraF25686326802026-01-20
00810053950524NOVEOS Cladosporium herbarumM0028632990Z2026-01-12
00810053950609NOVEOS Virginia Live Oak, Quercus virginianaT2188633260Z2025-10-03
00816879024128NOVEOS Virginia Live Oak, Quercus virginianaT21886332602025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950524NOVEOS 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
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