FDA.reportPublic FDA data

Tween 20

Primary DI
B502BSB00460
Brand
Tween 20
Company
BIO SB, INC.
Model
500 ml
Catalog number
BSB 0046
Device description
Tween 20 is a detergent and an emulsifier used in wash buffers and other buffers for immunohistochemistry and in situ hybridization procedures. It can be used in autostainers, capillary action slides, as well as manual staining procedures.
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B502BSB00460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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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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