FDA.report

Tinto PAX-8 (RM436)

Primary DI
B502BSB378670
Brand
Tinto PAX-8 (RM436)
Company
BIO SB, INC.
Model
BSB-3786-7
Catalog number
BSB-3786-7
Device description
Tinto PAX-8 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
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

Related Records

Contact Domains

Product Codes

CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB378670PrimaryHIBCC0

GMDN Terms

TermDefinition
Periosteal elevator, single-useA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume7Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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