FDA.reportPublic FDA data

Q-STAIN® QSX Enhancer

Primary DI
00850036867104
Brand
Q-STAIN® QSX Enhancer
Company
NOVODIAX, INC.
Model
QD28020-004
Catalog number
QD28020-004
Published
2022-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850036867104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036867104008500368671048500368671040850036867104

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry conjugated secondary antibody IVDOne or multiple conjugated immunoglobulins capable of binding to specific antigenic determinants, and intended to be used for the detection of primary antibodies bound to specific cell markers when testing biological tissues or clinical specimens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume4Milliliter

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041202419QSX-Enh-P HER2 (ASR)AP31063-004AP31063-0042023-03-20
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
00850041202426QSX-Enh-P ER (ASR)AP32052-004AP32052-0042023-03-20
00850041202433QSX-Enh-P PR (ASR)AP32053-004AP32053-0042023-03-20
00850036867159Q-STAIN® X AutostainerIA01-001IA01-0012022-02-04
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

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