FDA.reportPublic FDA data

NOVEOS Optics Tip Pack

Primary DI
00816879023107
Brand
NOVEOS Optics Tip Pack
Company
HYCOR BIOMEDICAL LLC
Model
119844-001
Published
2021-01-11
Public version status
Update
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
K182479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182479000NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinusHycor Biomedical2018-12-04DHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879023107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879023107008168790231078168790231070816879023107

GMDN Terms#

Term, Definition table
TermDefinition
General laboratory container, reusableA container (e.g., test tube, bottle, cup) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), biological specimens, and other materials associated with in the laboratory; it is not intended for in vitro diagnostic procedures. It is designed to withstand an extremely high-temperature environment (e.g., autoclaving) to enable repeated sterilization. It is typically made of high-temperature-resistant plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers (e.g., tissue culture). This is a reusable device.

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
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaF0188632330Z2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaF0368634210Z2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.F0408632420Z2026-05-29
00810053950227NOVEOS Salmon, Salmo salarF0418638910Z2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusF07563247Z2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisF2018633630Z2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraF2038632630Z2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisF2908633830Z2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaF01886323302026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.F04086324202026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraF20386326302026-05-29
00816879024548NOVEOS Salmon, Salmo salarF04186389102026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisF20186336302026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisF29086338302026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusF075632472026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCDHB2026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879024548NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024548NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCDHB2026-05-29