FDA.report

Tinto Cytomegalovirus (8B1.2, 1G5.2 & 2D4.2)

Primary DI
B502BSB5451ASR0
Brand
Tinto Cytomegalovirus (8B1.2, 1G5.2 & 2D4.2)
Company
BIO SB, INC.
Model
BSB 5451 (ASR)
Catalog number
BSB 5451 (ASR)
Device description
Tinto Cytomegalovirus is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
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
MVUReagents, specific, analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB5451ASR0PrimaryHIBCC0

GMDN Terms

TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Device Sizes

TypeValueUnit
Total Volume15Milliliter

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B502BSB52580CD45RA (4KB5) MMabConcentrate, 1 mlBSB 52582020-03-16
B502BSB74000TintoStainer Plus Automated SystemBSB-7400BSB-74002025-03-28
B502BSB7400100TintoStainer Plus Automated System MiniBSB-7400-10BSB-7400-102025-03-28
B502BSB7400600TintoStainer Plus Automated System LXBSB-7400-60BSB-7400-602025-03-28
B502BSB9420CS0Tryptase Control SlidesBSB-9420-CSBSB-9420-CS2025-03-28
B502BSB02010Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0201BSB 02012025-03-18
B502BSB0307CS05-Core Multi-Infectious Disease Cell Line Microarray Control SlidesBSB-0307-CSBSB-0307-CS2025-03-18
B502BSB0307S0Mohs Mouse/Rabbit PolyDetector DAB HRP BrownBSB 0307SBSB 0307S2025-03-18
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
B502BSB0352150PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-15BSB-0352-152025-03-18
B502BSB0352500PIN MultiDetector (CK 34BE12, p63 & AMACR)BSB-0352-50BSB-0352-502025-03-18
B502BSB0353500PNI Carcinoma MultiDetector (CK 5 & 6 Cocktail & NGFR)BSB-0353-50BSB-0353-502025-03-18
B502BSB03551000Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-100BSB-0355-1002025-03-18
B502BSB0355150Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-15BSB-0355-152025-03-18
B502BSB035550Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-5BSB-0355-52025-03-18
B502BSB0355500Mohs Mouse/Rabbit PolyDetector Plus DAB HRP BrownBSB-0355-50BSB-0355-502025-03-18
B502BSB03561000Mohs Mouse/Rabbit PolyDetector Plus HRP GreenBSB-0356-100BSB-0356-1002025-03-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
04251315801035MetaSystems ProbesMetaSystems Probes GmbHMVU2026-03-17
05055844935525CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935532CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935549CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935556CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935563CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935570CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935617CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
05055844935624CytoCell myProbesCYTOCELL LIMITEDMVU2026-03-17
00850051429936Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-02-26
00850051429882Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
00850051429899Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1AGILENT TECHNOLOGIES, INC.MVU2026-01-21
M663DF300120DiskFISHCELLAY, INC.MVU2026-01-06
M663DF300129DiskFISHCELLAY, INC.MVU2026-01-06
M663DF400590DiskFISHCELLAY, INC.MVU2026-01-06
M663DF402440DiskFISHCELLAY, INC.MVU2026-01-06
M663CKOF300120OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF302510OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF400590OligoFISHCELLAY, INC.MVU2026-01-06
M663OF4005903001OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF402440OligoFISHCELLAY, INC.MVU2026-01-06
00810034704009PE anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704016FITC anti-human TdTBIOLEGEND, INC.MVU2025-12-22
00810034704047Pacific Blue™ anti-human Granzyme BBIOLEGEND, INC.MVU2025-12-22
00810034704054Spark Violet™ 538 anti-human HLA-DRBIOLEGEND, INC.MVU2025-12-22