FDA.report

Tinto Calretinin (RM324)

Primary DI
B502BSB375730
Brand
Tinto Calretinin (RM324)
Company
BIO SB, INC.
Model
BSB-3757-3
Catalog number
BSB-3757-3
Device description
Tinto Calretinin 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
B502BSB375730PrimaryHIBCC0

GMDN Terms

TermDefinition
Calretinin protein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of calretinin protein in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume3Milliliter

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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