FDA.reportPublic FDA data

TintoReagent Container 30mL

Primary DI
B502BSB74570
Brand
TintoReagent Container 30mL
Company
BIO SB, INC.
Model
BSB-7457
Catalog number
BSB-7457
Device description
Accessory of the Tinto Stainer Plus Automated System
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
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
B502BSB74570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser specimen/reagent container carrier IVDA device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. 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
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
08435389830269HEATING OVEN H-PLUSBIOTECHNOLOGY INSTITUTE SLLXG2026-01-30
04250317501554PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317501578PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317536204PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317537577PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317554611PrecolumnChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317555281PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
04250317558022PrefilterChromsystems Instruments + Chemicals GmbHLXG2026-01-22
09120123910015Anchor Tips, 300uLSTRATEC Consumables GmbHLXG2026-01-14
09120123911012Stackable Cuvette, 1mLSTRATEC Consumables GmbHLXG2026-01-14
06979203760025Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760032Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760049Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760056Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-29
06979203760018Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdLXG2025-12-08
04049016152101Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04049016152125Reagent tray for incubation of slidesEUROIMMUN Medizinische Labordiagnostika AGLXG2025-11-27
04250317510174TubeChromsystems Instruments + Chemicals GmbHLXG2025-07-31
04260170881090Q-graft control deviceHuman Med AGLXG2025-07-30
04260170881106Q-graft collectorHuman Med AGLXG2025-07-30
14260170881608Q-graft disposable setHuman Med AGLXG2025-07-30
14260170881615Q-graft centrifugation setHuman Med AGLXG2025-07-30
17290020288001CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288018CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288025CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288032CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288049CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288056CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288063CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20
17290020288070CellSHILEDEQUASHIELD MEDICAL LTDLXG2025-07-20