FDA.reportPublic FDA data

Wheat

Primary DI
00816879021196
Brand
Wheat
Company
HYCOR BIOMEDICAL LLC
Model
F004
Catalog number
74237
Device description
A 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.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00816879021196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879021196008168790211968168790211960816879021196

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010558476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810053950586NOVEOS Mulberry, Morus albaT0708633250Z2025-08-27
00816879024500NOVEOS Mulberry, Morus albaT07086332502025-08-27
00810053950623NOVEOS Lamb's Quarters, Goosefoot, Chenopodium albumW0108633340Z2025-08-25
00816879024159NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium albumW01086333402025-08-25

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