FDA.reportPublic FDA data

Desmin Control Slides

Primary DI
B502BSB54620
Brand
Desmin Control Slides
Company
BIO SB, INC.
Model
Control Slides, 5
Catalog number
BSB 5462
Device description
Desmin, Control
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B502BSB54620PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Desmin protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of desmin protein in a clinical specimen.

Sterilization Methods#

Method table
Method

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
false
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
B502BSB9420CS0Tryptase Control SlidesBIO SB, INC.LJG2025-03-28
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0308CS02-Core SV-40 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0309CS02-Core HHV-8 Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0310CS02-Core Adenovirus Cell Line Microarray Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB0333CS02-core Human PIN TMA Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9000CS0A-1-Antichymotrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9001CS0A-1-Antitrypsin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9002CS0ACE2 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9003CS0ACTH Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9004CS0Actin Muscle Specific Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9005CS0Actin Smooth Muscle Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9006CS0Adenovirus Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9007CS0Adipophilin/ADRP Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9008CS0Albumin Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9010CS0ALK-1/CD246 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9011CS0Alpha Synuclein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9012CS0Alpha-Fetoprotein Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9013CS0AMACRacemase/P504S Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9014CS0Amyloid A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9015CS0Amyloid Beta Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9016CS0Androgen Receptor Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9018CS0Annexin VII Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9021CS0ATM Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.LJG2025-03-18