FDA.reportPublic FDA data

PolyDetector Liquid DAB HRP Brown kit

Primary DI
B502BSB0018A0
Brand
PolyDetector Liquid DAB HRP Brown kit
Company
BIO SB, INC.
Model
5000 tests
Catalog number
BSB 0018A
Device description
PolyDetector DAB HRP Brown Substrate-Chromogen used in HRP Detection systems for demonstration of tissue antigens or nucleic acids in formalin-fixed paraffin-embedded tissues, frozen sections, cytosmears, and cell preparations.
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B502BSB0018A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chromogenic substrate reagent IVDA reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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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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