FDA.reportPublic FDA data

ihcDirect® CD20 Ab Conjugate 15mL

Primary DI
00850030934543
Brand
ihcDirect® CD20 Ab Conjugate 15mL
Company
NOVODIAX, INC.
Model
H32029-R015
Catalog number
K32029-015
Device description
Clone R272
Published
2021-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000596078PreviousGS10
00850030934543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000596078008500005960788500005960780850000596078
00850030934543008500309345438500309345430850030934543

GMDN Terms#

Term, Definition table
TermDefinition
CD20 cell marker IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of CD20 cell marker in a clinical specimen, using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature21 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5103423043support@novodiax.com

Regulatory Flags#

DUNS number
965326957
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00850036867753Q-STAIN® QSX-Enh-P WT-1QP32045-004QP32045-0042023-11-21
00850036867760Q-STAIN® QSX-Enh-F WT-1QF32045-004QF32045-0042023-11-21
00850036867777Q-STAIN® QSX-Enh-P Gal-3QP32025-004QP32025-0042023-11-21
00850036867784Q-STAIN® QSX-Enh-F Gal-3QF32025-004QF32025-0042023-11-21
00850036867791Q-STAIN® QSX-Enh-P TROP2QP32044-004QP32044-0042023-11-21
00850036867807Q-STAIN® QSX-Enh-F TROP2QF32044-004QF32044-0042023-11-21
00850041202365Q-STAIN® QSX-Enh-F CgAQF32035-004QF32035-0042023-11-21
00850041202372Q-STAIN® QSX-Enh-P CgAQP32035-004QP32035-0042023-11-21
00850036867449Q-STAIN® QSX-Enh-F CD34QF31046-004QF31046-0042023-03-20
00850036867555Q-STAIN® QSX-Enh-P CD34QP31046-004QP31046-0042023-03-20
00850041202389ihc CD34 Ab (3mL)KF31046-003F31046-R003 / KF31046-0032023-03-20
00850041202396ihc CD34 Ab (5mL)KF31046-005F31046-R005 / KF31046-0052023-03-20
00850041202419QSX-Enh-P HER2 (ASR)AP31063-004AP31063-0042023-03-20
00850041202426QSX-Enh-P ER (ASR)AP32052-004AP32052-0042023-03-20
00850041202433QSX-Enh-P PR (ASR)AP32053-004AP32053-0042023-03-20
00850036867166Q-STAIN® QSX-Enh-P GFAP QP32002-004QP32002-0042022-07-21
00850036867173Q-STAIN® QSX-Enh-P CD20 QP32029-004QP32029-0042022-07-21
00850036867180Q-STAIN® QSX-Enh-P VimentinQP32021-004QP32021-0042022-07-21
00850036867234Q-STAIN® QSX-Enh-F Ki67 QF32001-004QF32001-0042022-07-21
00850036867258Q-STAIN® QSX-Enh-F SYN QF32034-004QF32034-0042022-07-21

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