FDA.report

ihcDirect® Napsin A Ab, 5mL

Primary DI
00850000596702
Brand
ihcDirect® Napsin A Ab, 5mL
Company
NOVODIAX, INC.
Model
K32043-005
Catalog number
K32043-005
Device description
Clone R1010
Published
2020-10-26
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

Related Records

Contact Domains

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850000596702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000596702008500005967028500005967020850000596702

GMDN Terms

TermDefinition
Napsin A 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 napsin A in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume5Milliliter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature21 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336182765VENTANA pan-TRK (EPR17341) AssayVentana Medical Systems, Inc.NJT2026-03-16
00847627042637Pan TRK [RM423]BIOCARE MEDICAL LLCNJT2026-02-19
07613336231395PAX-8 (SP348) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-02-16
00847627042279CK7BIOCARE MEDICAL LLCNJT2026-01-29
00847627042033DesminBIOCARE MEDICAL LLCNJT2026-01-13
00847627042835CD19BIOCARE MEDICAL LLCNJT2026-01-13
00847627041937Myeloperoxidase (P)BIOCARE MEDICAL LLCNJT2026-01-06
00847627042514VimentinBIOCARE MEDICAL LLCNJT2026-01-06
00615233011435Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233011442Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233013996Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014009Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014474Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014481Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014559Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014566Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00847627042019CD43BIOCARE MEDICAL LLCNJT2025-12-16
00847627042118Cytokeratin 18 (CK18)BIOCARE MEDICAL LLCNJT2025-12-16
00847627042491CD79aBIOCARE MEDICAL LLCNJT2025-12-16
00847627042576Cytokeratin [AE1] LMWBIOCARE MEDICAL LLCNJT2025-12-16
00847627042897CD103 (RM)BIOCARE MEDICAL LLCNJT2025-12-16
04015630971176Bluing ReagentVentana Medical Systems, Inc.NJT2025-12-15
04015630971299Amplification KitVentana Medical Systems, Inc.NJT2025-12-15
04015630972128CONFIRM anti-ALK1 (ALK01) Primary AntibodyVentana Medical Systems, Inc.NJT2025-12-15
07613336158357VENTANA Red ISH DIG Detection KitVentana Medical Systems, Inc.NJT2025-12-15
07613336158418VENTANA Silver ISH DNP Detection KitVentana Medical Systems, Inc.NJT2025-12-15
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNJT2025-11-25
00847627042132CD7BIOCARE MEDICAL LLCNJT2025-11-25
00847627042965Pan Melanoma Cocktail-2BIOCARE MEDICAL LLCNJT2025-11-17
00847627039095Desmoglein 3BIOCARE MEDICAL LLCNJT2025-09-19