ACCURUN® 2000-0001

GUDID 00816784020024

ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL

SERACARE LIFE SCIENCES, INC.

Multiple blood-borne virus antigen/antibody IVD, control
Primary Device ID00816784020024
NIH Device Record Key4716f605-87b5-42d9-9568-3e3f550e5040
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCURUN®
Version Model Number2000-0001
Catalog Number2000-0001
Company DUNS106267123
Company NameSERACARE LIFE SCIENCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816784020024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSFKit, Quality Control For Blood Banking Reagents

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [ACCURUN®]

00816784020888ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
00816784020871ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
00816784020819ACCURUN 872 HPV DNA 10 x 1.0 mL Cells 10 x 1.0 mL Diluent
00816784020802ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL
00816784020789ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
00816784020772ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
00816784020765ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
00816784020710ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL
00816784020703ACCURUN 873 HPV DNA 20 x 4.0 mL
00816784020697ACCURUN 342 Series 700 CT/NG 10 x 1.0 mL
00816784020680ACCURUN 342 Series 100 CT/NG 10 x 1.0 mL
00816784020673ACCURUN 841 CT/NG 5 x 1.0 mL
00816784020666ACCURUN 381 HPV TYPE 16 & 18 mRNA 10 x 1.0 mL - HPV Type 16 10 x 1.0 mL - HPV Type 18
00816784020659ACCURUN 378 Series 5000 HPV DNA 20 x 4.0 mL
00816784020642ACCURUN 372 Series 600 HPV DNA 10 x 1.0 mL SiHa and H9 Cells 10 x 1.0 mL Diluent
00816784020635ACCURUN 372 Series 400 10 x 0.8 mL SiHa and H9 Cells 10 x 2.0 mL Diluent
00816784020628ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL
00816784020611ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.2 mL
00816784020604ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL
00816784020598ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL
00816784020581ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL
00816784020574ACCURUN 315 Series 400 HIV-1 RNA 5 x 1.0 mL
00816784020567ACCURUN 315 Series 200 HIV-1 RNA 5 x 1.0 mL
00816784020550ACCURUN 315 Series 150 HIV-1 RNA 10 x 1.2 mL
00816784020536ACCURUN 305 Series 400 HCV RNA 5 x 4.0 mL
00816784020529ACCURUN 305 Series 300 HCV RNA 5 x 1.0 mL
00816784020512ACCURUN 305 Series 100 HCV RNA 5 x 1.0 mL
00816784020505ACCURUN 305 Series 150 HCV RNA Positive Control 10 x 1.2 mL
00816784020499ACCURUN 190 Anti - Trypanosoma cruzi 6 x 3.5 mL
00816784020482ACCURUN 156 Reagin (Syphilis) 3 x 1.0 mL
00816784020475ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 3 x 2.0 mL
00816784020468ACCURUN 155 Series 5000 Anti-Treponema (Syphilis) 12 x 3.5 mL
00816784020451ACCURUN 155 Series 2000 Anti-Treponema (Syphilis) 3 x 2.0 mL
00816784020444ACCURUN 146 CMV IgM Positive Control 1 x 1.0 mL
00816784020437ACCURUN 145 CMV IgG 1 x 1.0 mL
00816784020420ACCURUN 141 Rubella IgM 1 x 1.0 mL
00816784020413ACCURUN 140 Rubella IgG 1 x 5.0 mL
00816784020406ACCURUN 136 Toxoplasma IgM 1 x 1.0 mL
00816784020390ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
00816784020383ACCURUN 132 Borrelia burgdorferi IgM 1 x 1.0 mL
00816784020376ACCURUN 130 Borrelia burgdorferi IgG 1 x 1.0 mL
00816784020369ACCURUN 127 Anti-Hepatitis Delta 1 x 1.0 mL
00816784020352ACCURUN 125 Anti-HBs 6 x 3.5 mL
00816784020345ACCURUN 125 Anti-HBs 1 x 5.0 mL
00816784020338ACCURUN 121 HAV IgM 6 x 3.5 mL
00816784020321ACCURUN 121 HAV IgM 1 x 5.0 mL
00816784020314ACCURUN 120 HAV IgG 1 x 5.0 mL
00816784020307ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL
00816784020291ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL
00816784020284ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL

Trademark Results [ACCURUN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCURUN
ACCURUN
90099182 not registered Live/Pending
AccuRun LLC
2020-08-07
ACCURUN
ACCURUN
75198245 2109153 Live/Registered
SERACARE LIFE SCIENCES, INC.
1996-11-04

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