FDA.report

Tinto Helicobacter Pylori, MMab

Primary DI
B502BSB26770
Brand
Tinto Helicobacter Pylori, MMab
Company
BIO SB, INC.
Model
Predilute, 3 ml
Catalog number
BSB 2677
Device description
Tinto Helicobacter Pylori is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5,
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB26770PrimaryHIBCC0

GMDN Terms

TermDefinition
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori bacteria in a clinical specimen.

Sterilization Methods

Method

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
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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