FDA Registration
Active
🇺🇸 United States
M005 Candida albicans
Reg #: 2016473
·
FEI: 1000125787
·
Expires 2025
Products
1
Proprietary Names
242
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HYCOR BIOMEDICAL
- Registration Number
- 2016473
- FEI Number
- 1000125787
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7272 Chapman Ave
- City
- GARDEN GROVE
- State
- CA
- ZIP
- 92841
- Country
- US
Owner / Operator
- Firm Name
- Hycor Biomedical
- Operator Number
- 2016473
- Address
- 7272 Chapman Avenue
- City
- Garden Grove
- State
- CA
- Postal Code
- 92841
- Country
- US
- Correspondent
- Aashrey Kaul
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2014-12-11 |
Proprietary Names
M005 Candida albicans
FX27 Food Mix 27
F084 Kiwi
Cuvette Wash Pack
FX25 Food Mix 25
W018 Sheep Sorrel
D201 House Dust Mite
D202 Der p 1, House Dust Mite
T220 Bet v 4, Birch
D073 Storage Mite
T061 Sycamore
G004 Meadow Fescue
W036 Rabbit Bush
FX28 Food Mix 28
E087 Rat Epithelium, Serum and Urine Proteins
WX05 Weed Mix 5
T006 Mountain Juniper
E082 Rabbit Epithelium
D203 Der p 2, House Dust Mite
E072 Mouse Urine
FX26 Food Mix 26
M002 Cladosporium herbarum
G015 Cultivated Wheat
F001 Egg White
E071 Mouse Epithelium
P001 Ascaris
F351 Pen a 1 Tropomyosin, Shrimp
F440 Cor a 9, Hazelnut
FX77 Food Mix 77
F235 Lentil
F427 Ara h 9 LTP, Peanut
G001 Sweet Vernal Grass
F434 Mal d 1 PR-10, Apple
F049 Apple
F323 Gal d 3 Conalbumin, Egg
F002 Cows Milk
W019 Wall Pellitory
W013 Cocklebur
T025 European Ash
G215 Phl p 5b, Timothy
F026 Pork
E211 Rabbit Urine Proteins
F232 Gal d 2 Ovalbumin, Egg
F422 Ara h 1, Peanut
K208 Gal d 4 Lysozyme, Egg
F085 Celery
E075 Rat Serum Proteins
G010 Johnson Grass
W014 Common Pigweed
F047 Garlic
D001 House Dust Mite
FX24 Food Mix 24
D003 House Dust Mite
I003 Common Wasp, Yellow Jacket
E076 Mouse Serum Proteins
E220 Fel d 2 Cat Serum Albumin, Cat
F215 Lettuce
T221 Bet v 2, Bet v 4, Birch
F033 Orange
E088 Mouse Epithelium, Serum and Urine Proteins
T012 Willow
EX01 Domestic Animal Mix
F424 Ara h 3, Peanut
F045 Yeast
T225 Bet v 6, Birch
T215 Bet v 1 PR-10, Birch
F425 Cor a 8 LTP, Hazelnut
E005 Dog Dander
E226 Can f 5, Dog
T010 Walnut
E086 Duck Feathers
F352 Ara h 8 PR-10, Peanut
T026 Acacia, Silver Wattle
F441 Jug r 1, Walnut
G212 Phl p 12, Timothy
F013 Peanut
F010 Sesame Seed
F024 Shrimp
G211 Phl p 11, Timothy
F300 Goat Milk
G017 Bahia Grass
FX05 Food Mix
E085 Chicken Feathers
I071 Mosquito
T218 Virginia Live Oak
E221 Can f 3 Dog Serum Albumin, Dog
G007 Common Reed
GX01 Grass Mix 1
E227 Equ c 1, Horse
F012 Pea
IgE Negative Control Pack
F079 Gluten, Wheat
T014 Cottonwood Tree
E074 Rat Urine Proteins
E006 Guinea Pig Epithelium
E206 Rabbit Serum Proteins
F284 Turkey
F443 Ana o 3, Cashew Nut
I001 Honeybee
F037 Blue Mussel
T002 Gray Alder
W011 Russian Thistle
FX01 Nut Mix
E070 Goose Feathers
G008 Meadow Grass, Kentucky Blue
D072 Storage Mite
W230 Amb a 1, Ragweed
E215 Pigeon Feathers
F007 Oat
M218 Asp f 1, Aspergillus fumigatus
F245 Egg
F092 Banana
Probe Wash Pack
F233 Gal d 1 Ovomucoid, Egg
E232 Can f 1, Can f 3, Can f 5, Dog
E001 Cat Dander
Wash Buffer Concentrate Pack
NOVEOS flex Fluo Beads Pack
F003 Cod
G009 Redtop, Bentgrass
W009 English Plantain
Reagent Pack Diluent A
T008 Elm
F325 Sheep Milk
W012 Goldenrod
F041 Salmon
W008 Dandelion
F076 Bos d 4 alpha-lactalbumin, Milk
G012 Cultivated Rye
F419 Pru p 1 PR-10, Peach
T030 White Birch
T004 Hazelnut Tree
D205 Der p 10, House Dust Mite
H001 House Dust - Greer
D070 Storage Mite
G003 Cocksfoot
T001 Maple Box Elder
E101 Can f 1, Dog
E228 Fel d 4, Cat
F202 Cashew Nut
IgE Positive Control Pack
F201 Pecan Nut
W043 Common Sagebrush
F017 Hazelnut
F027 Beef
SX01 NOVEOS Inhalant Screen
D002 House Dust Mite
IgE Calibrator Antibody Pack
F094 Pear
F083 Chicken
F031 Carrot
T003 Common Silver Birch
F203 Pistachio Nut
FX99 Food Tree Nut Mix
E102 Can f 2, Dog
Reagent Pack Fluo Beads
E004 Cow Dander
F014 Soybean
F345 Macadamia Nut
T005 American Beech
M003 Aspergillus fumigatus
F256 Walnut
F009 Rice
Reagent Pack Substrate
TX09 Tree Mix 9
G209 Phl p 6, Timothy
I211 Ves v 1, Common Wasp
F004 Wheat
I075 European Hornet
E073 Rat Epithelium
T011 Maple Leaf Sycamore, London Plane
F025 Tomato
T007 Oak
F096 Avocado
IgE Calibrator Pack (6 levels - Cal 7, Cal .35, Cal .70, Cal 3.5, Cal 17.5, Cal 100)
T023 Mediterranean Cypress
F036 Coconut
FX02 Seafood Mix
F011 Buckwheat
D209 Der p 23, House Dust Mite
T009 Olive Tree
W007 Marguerite, Ox-eye Daisy
G205 Phl p 1, Timothy
F420 Pru p 3 LTP, Peach
W001 Common Ragweed
E003 Horse Dander
I070 Fire Ant
Total IgE Capture Reagent
T224 Ole e 1, Olive
E219 Chicken Serum Proteins
F439 Cor a 14, Hazelnut
M229 Alt a 1
F008 Maize, Corn
F089 Mustard
F447 Ara h 6, Peanut
G006 Timothy Grass
I006 German Cockroach
F020 Almond
F290 Oyster
W231 Art v 1, Mugwort
F018 Brazil Nut
T015 White Ash
I005 Yellow Hornet
T041 White Hickory
G013 Velvet Grass
W046 Dog Fennel
W211 Par j 2 LTP, Wall Pellitory
W002 Western Ragweed
T216 Bet v 2 Profilin, Birch
T022 Pecan, Hickory
Total IgE Diluent
E204 Bos d 6 BSA, Cow
G210 Phl p 7, Timothy
Reagent Pack Conjugate IgE
E094 Fel d 1, Cat
F078 Bos d 8 Casein, Milk
GX03 Grass Mix 03
F080 Lobster
F006 Barley
F075 Egg Yolk
F005 Rye
M207 Aspergillus niger
W006 Mugwort
D071 Storage Mite
F077 Bos d 5 beta-lactoglobulin, Milk
F428 Cor a 1 PR-10, Hazelnut
G005 Rye Grass
F442 Jug 3 LTP, Walnut
W010 Lambs Quarter, Goosefoot
F309 Chickpea
I209 Ves v 5, Common Wasp
K082 Latex
F023 Crab
F423 Ara h 2, Peanut
F040 Tuna
F207 Clam
G002 Bermuda Grass
F258 Squid
M006 Alternaria alternata
G206 Phl p 2, Timothy
TX05 Tree Mix 5
T070 Mulberry
Establishment Types
Manufacture Device in the United States for Export Only