FDA.reportPublic FDA data

C1 Esterase Inhibitor RID plate package

Primary DI
B1761354
Brand
C1 Esterase Inhibitor RID plate package
Company
KENT LABORATORIES INC
Model
1
Catalog number
135411
Device description
Radial immunodiffusion plate package for human C1 Esterase Inhibitor
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZQPlates And Equipment, Radial Immunodiffusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZQPlates And Equipment, Radial ImmunodiffusionImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761354PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1 inhibitor IVD, kit, precipitation/immunodiffusionA collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1 inhibitor in a clinical specimen, using a precipitation/immunodiffusion method. It is used to assess C1 inhibitor activity which is associated with hereditary angioneurotic oedma.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3603988641donald@kentlabs.com

Regulatory Flags#

DUNS number
093642254
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1761250Antiserum to Human Transferrin11250022016-09-24
B1761254Transferrin RID plate package11254112016-09-24
B1761255Transferrin RID plate kit11255112016-09-24
B1761080Antiserum to Human Properdin11080022016-09-24
B1761082Anti Human Properdin FITC11082022016-09-24
B1761210Antiserum to Human C-3b Inactivator (factor I)11210022016-09-24
B1761212Anti Human C3b Inactivator FITC11212022016-09-24
B1761230Antiserum to Human Alpha 1 Acid Glycoprotein11230022016-09-24
B176131Antiserum to Human Myoglobin11310022016-09-24
B1761500Antiserum to Apolipoprotein A-111500022016-09-24
B1761520Antiserum to Apolipprotein B11520022016-09-24
B1761540Antiserum to Human Prealbumin11540022016-09-24
B1761000Antiserum to Whole Human Serum11000022016-09-24
B1761010Antiserum to Human IgG (gamma chain specific)11010022016-09-24
B1761011Rhodamine conjugated antiserum to Human IgG11011022016-09-24
B1761012Anti Human IgG FITC11012022016-09-21
B1761014IgG RID Plate Package11014112016-09-24
B1761015IgG RID Plate Kit11015112016-09-24
B1761018Peroxidase conjugated Antiserum to Human IgG11018722016-09-24
B1761020Antiserum to Human IgA (alpha chain specific)11020022016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840733101397Fungal Immunodiffusion Plates - 4 SeriesMERIDIAN BIOSCIENCE, INC.JZQ2019-11-21
00840733101403Fungal Immunodiffusion Plates - 1 SeriesMERIDIAN BIOSCIENCE, INC.JZQ2019-11-21
B1761024IgA RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761025IgA RID plate KitKENT LABORATORIES INCJZQ2016-09-24
B1761065C-3 Proactivator RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761094C-4 (b1e) RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761095C-4 (b1e) RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761104C-5 (b1f) RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761105C-5 (b1f) RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761114C1q RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761115C1q RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761124Haptoglobin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761125Haptoglobin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761224Alpha 1 Antitrypsin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761225Alpha 1 Antitrypsin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761234Alpha 1 Acid Glycoprotein RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761235Alpha 1 Acid Glycoprotein RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761244Alpha 2 Macroglobulin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761245Alpha 2 Macroglobulin RID kitKENT LABORATORIES INCJZQ2016-09-24
B1761254Transferrin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761255Transferrin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761264Ceruloplasmin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761265Ceruloplasmin RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761274IgD RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761275IgD RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761344C Reactive Protein RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761345C Reactive Protein RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761355C1 Esterase Inhibitor RID plate kitKENT LABORATORIES INCJZQ2016-09-24
B1761494Hemopexin RID plate packageKENT LABORATORIES INCJZQ2016-09-24
B1761544Prealbumin RID plate packageKENT LABORATORIES INCJZQ2016-09-24