FDA.reportPublic FDA data

MUC4 (RBT-MUC4)

Primary DI
B502BSB384110
Brand
MUC4 (RBT-MUC4)
Company
BIO SB, INC.
Model
BSB-3841-1
Catalog number
BSB-3841-1
Device description
MUC4 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.7
Published
2025-03-18
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
B502BSB384110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mucin 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 mucin protein in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)561-1145sales@biosb.com

Regulatory Flags#

DUNS number
102855447
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
B502BSB52580CD45RA (4KB5) MMabConcentrate, 1 mlBSB 52582020-03-16
B502BSB74000TintoStainer Plus Automated SystemBSB-7400BSB-74002025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBSB-7400-10BSB-7400-102025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBSB-7400-60BSB-7400-602025-03-28
B502BSB9420CS0Tryptase Control SlidesBSB-9420-CSBSB-9420-CS2025-03-28
B502BSB02010Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0201BSB 02012025-03-18
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBSB-0307-CSBSB-0307-CS2025-03-18
B502BSB0307S0Mohs Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0307SBSB 0307S2025-03-18
B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBSB-0308-CSBSB-0308-CS2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBSB-0309-CSBSB-0309-CS2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBSB-0310-CSBSB-0310-CS2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBSB-0333-CSBSB-0333-CS2025-03-18
B502BSB0352150PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-15BSB-0352-152025-03-18
B502BSB0352500PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-50BSB-0352-502025-03-18
B502BSB0353500PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR)BSB-0353-50BSB-0353-502025-03-18
B502BSB03551000Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-100BSB-0355-1002025-03-18
B502BSB0355150Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-15BSB-0355-152025-03-18
B502BSB035550Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-5BSB-0355-52025-03-18
B502BSB0355500Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-50BSB-0355-502025-03-18
B502BSB03561000Mohs Mouse/Rabbit PolyDetector Plus HRP GreenBSB-0356-100BSB-0356-1002025-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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