FDA.reportPublic FDA data

TintoAutomation Probe Cleaner Kit

Primary DI
B502BSB74630
Brand
TintoAutomation Probe Cleaner Kit
Company
BIO SB, INC.
Model
BSB-7463
Catalog number
BSB-7463
Device description
The TintoAutomation Cleaner is a 3-component cleaning solution for removal of DAB chromogen stains and precipitates from the TintoStainer Plus automated platform, glassware, labware, or other surfaces that come in contact with DAB.
Published
2025-03-18
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
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B502BSB74630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide trayA device designed to safely store and organize stained microscope slides for their protection and presentation. This device is available as flat tray made of plastic materials in which the slides are placed flat into recesses. It will typically be made of white material to provide a background that facilitates slide viewing. This device will typically be placed in a microscope slide storage cabinet. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
102855447
Device count
1
Premarket exempt
true
Kit
true
Manufacturing date on label
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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