FDA.reportPublic FDA data

Glypican-3 control slides

Primary DI
B502BSB62460
Brand
Glypican-3 control slides
Company
BIO SB, INC.
Model
Control Slides, 5
Catalog number
BSB 6246
Device description
Glypican-3 Control
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
B502BSB62460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain control IVDA prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102855447
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B502BSB74540TintoReagent Container 7mLBSB-7454BSB-74542025-03-18
B502BSB74550TintoReagent Tube with Cap 6mLBSB-7455BSB-74552025-03-18
B502BSB9436CS0APOE4 Control SlidesBSB-9436-CSBSB-9436-CS2025-03-18
B502BSB5036ASR0Tinto Adenovirus (20/11 and 2/6)BSB 5036 (ASR)BSB 5036 (ASR)2025-03-18
B502BSB5037ASR0Tinto Adenovirus (20/11 and 2/6)BSB 5037 (ASR)BSB 5037 (ASR)2025-03-18
B502BSB5038ASR0Tinto Adenovirus (20/11 and 2/6)BSB 5038 (ASR)BSB 5038 (ASR)2025-03-18
B502BSB5039ASR0Adenovirus (20/11 and 2/6)BSB 5039 (ASR)BSB 5039 (ASR)2025-03-18
B502BSB5040ASR0Adenovirus (20/11 and 2/6)BSB 5040 (ASR)BSB 5040 (ASR)2025-03-18
B502BSB5041ASR0Adenovirus (20/11 and 2/6)BSB 5041 (ASR)BSB 5041 (ASR)2025-03-18
B502BSB50360Tinto Adenovirus, MMabPredilute, 3 ml BSB 50362020-06-01
B502BSB50370Tinto Adenovirus, MMabPredilute, 7 ml BSB 50372020-06-01
B502BSB50380Tinto Adenovirus, MMabPredilute, 15 ml BSB 50382020-06-01
B502BSB50390Adenovirus MMabConcentrate, 0.1 ml BSB 50392020-03-16
B502BSB50400Adenovirus MMabConcentrate, 0.5 ml BSB 50402020-03-16
B502BSB50410Adenovirus MMabConcentrate, 1 ml BSB 50412020-03-16
B502BSB9008CS0Albumin Control SlidesBSB-9008-CSBSB-9008-CS2025-03-18
B502BSB3000CS1Albumin/FITC control slidescontrol slides, 5BSB 3000-CS2020-07-30
B502BSB30180Albumin control slidesControl Slides, 5BSB 30182020-06-30
B502BSB52580CD45RA (4KB5) MMabConcentrate, 1 mlBSB 52582020-03-16
B502BSB74000TintoStainer Plus Automated SystemBSB-7400BSB-74002025-03-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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