FDA.reportPublic FDA data

BeckmanCoulter

Primary DI
15099590748999
Brand
BeckmanCoulter
Company
IMMUNOTECH
Model
C78083
Catalog number
C78083
Device description
CD200-SuperNova v786
Published
2021-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
15099590748999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959074899915099590748999

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
270264732
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807160Anti-TCR Cß1 (TRBC1)-FITCD32829D328292026-06-25
15099590719531Access PCTC53987C539872020-01-31
15099590795443CD25-SNv650C97990C979902025-10-01
15099590795450CD33-SNv650C97991C979912025-10-01
15099590795467CD56-SNv650C97992C979922025-10-01
15099590795474CD7-SNv650C97993C979932025-10-01
15099590795481CD14-SNv650C97994C979942025-10-01
15099590795498CD20-SNv650D05546D055462025-10-01
15099590796228CD8-SNv786D17894D178942025-10-01
15099590796235CD23-SNv786D17895D178952025-10-01
15099590796242CD7-SNv786D17896D178962025-10-01
15099590796266CD4-SNv605D17898D178982025-10-01
15099590796273CD22-SNv605D17900D179002025-10-01
15099590748098BeckmancoulterC76796C767962025-03-05
15099590748128BeckmancoulterC76799C767992025-03-05
15099590748159BeckmancoulterC76802C768022025-03-05
15099590748180BeckmancoulterC76805C768052025-03-05
15099590748210BeckmancoulterC76808C768082025-03-05
15099590748241BeckmancoulterC76811C768112025-03-05
15099590748272BeckmancoulterC76814C768142025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22