FDA UDI In Commercial Distribution 🇺🇸 United States

PolyDetector AP Blocker

DI: B502BSB00550 · Model: 15 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
PolyDetector AP Blocker
Primary DI
B502BSB00550
Version / Model
15 ml
Catalog Number
BSB 0055
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-30
Public Version
1
Public Version Date
2020-10-08
Public Version Status
New
Public Device Record Key
346e77c1-49ff-43fe-8582-5bc9dcd239e6

Device Description

PolyDetector AP Blocker is used to block the endogenous alkaline phosphatase enzymes that naturally occur in cells and tissue sections without affecting antigens or nucleic acids.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PPM General Purpose Reagent

GMDN Terms

Code Name
57767 Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Identifiers

Type ID
Primary B502BSB00550