FDA.reportPublic FDA data

NOVEOS Common Silver Birch, Betula verrucosa

Primary DI
00816879023671
Brand
NOVEOS Common Silver Birch, Betula verrucosa
Company
HYCOR BIOMEDICAL LLC
Model
T003
Catalog number
63308
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
DHBSystem, Test, Radioallergosorbent (Rast) Immunological
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalImmunology2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242531000NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay AnalyzHycor Biomedical2025-04-23DHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879023671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879023671008168790236718168790236710816879023671

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
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
00816879028393NOVEOS Cladosporium herbarumM00286329902026-01-12
00810053950609NOVEOS Virginia Live Oak, Quercus virginianaT2188633260Z2025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCDHB2026-01-20
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCDHB2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCJJE2026-01-20