FDA.reportPublic FDA data

QSX-Enh-P ER (ASR)

Primary DI
00850041202426
Brand
QSX-Enh-P ER (ASR)
Company
NOVODIAX, INC.
Model
AP32052-004
Catalog number
AP32052-004
Device description
Clone R292
Published
2023-03-20
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
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041202426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041202426008500412024268500412024260850041202426

GMDN Terms#

Term, Definition table
TermDefinition
Estrogen (oestrogen)/progesterone receptor IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.

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
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000596009ihcDirect® AE1/AE3 AbsK31007-005K31007-0052020-06-22
00850000596016ihcDirect® AE1/AE3 AbsK31007-015K31007-0152020-06-22
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
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

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