FDA.reportPublic FDA data

Hytec Specific IgE Reference Disc 100T MCS

Primary DI
00081687902207
Brand
Hytec Specific IgE Reference Disc 100T MCS
Company
HYCOR BIOMEDICAL LLC
Model
74112
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHBSystem, Test, Radioallergosorbent (Rast) Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081687902207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081687902207000816879022070816879022070081687902207

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 an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

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
Serial number
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
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCDHB2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCDHB2026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCDHB2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCDHB2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCDHB2026-01-20
00810053950500NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879024555NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879028010NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCDHB2026-01-20
00816879023251NOVEOS IgE Calibrator SetHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023534NOVEOS Egg White, Gallus gallusHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023541NOVEOS Cow's Milk, Bos taurusHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023626NOVEOS Alternaria alternataHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023633NOVEOS Oak, Quercus albaHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023671NOVEOS Common Silver Birch, Betula verrucosaHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879023923NOVEOS Bermuda Grass, Cynodon dactylonHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879024227NOVEOS Johnson Grass, Sorghum halepenseHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879024272NOVEOS Dog Dander, Canis familiarisHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879024302NOVEOS Common Ragweed, Ambrosia artemisiifoliaHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879028829NOVEOS Diluent A KitHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879028836NOVEOS Conjugate IgEHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879028850NOVEOS Substrate PackHYCOR BIOMEDICAL LLCDHB2025-05-12
00816879028881NOVEOS Fluo BeadsHYCOR BIOMEDICAL LLCDHB2025-05-12