FDA.reportPublic FDA data

Mycobacterium tuberculosis RPab

Primary DI
L502BSB2995
Brand
Mycobacterium tuberculosis RPab
Company
BIO SB, INC.
Model
Concentrate, 0.1 ml
Catalog number
BSB 2995
Device description
Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
Published
2020-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
L502BSB2995PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mycobacterium tuberculosis 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 the bacteria Mycobacterium tuberculosis in a clinical specimen.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B502BSB74540TintoReagent Container 7mLBSB-7454BSB-74542025-03-18
B502BSB74550TintoReagent Tube with Cap 6mLBSB-7455BSB-74552025-03-18
B502BSB9436CS0APOE4 Control SlidesBSB-9436-CSBSB-9436-CS2025-03-18
B502BSB5036ASR0Tinto Adenovirus (20/11 and 2/6)BSB 5036 (ASR)BSB 5036 (ASR)2025-03-18
B502BSB5037ASR0Tinto Adenovirus (20/11 and 2/6)BSB 5037 (ASR)BSB 5037 (ASR)2025-03-18
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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