Amplichek 12000528

GUDID 03610520530061

Amplichek I Level 1 (An assayed nucleic acid control.)

BIO-RAD LABORATORIES, INC.

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, control
Primary Device ID03610520530061
NIH Device Record Keyac3f8036-17d5-4ac2-a6c7-0bf94896b0b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmplichek
Version Model Number12000528
Catalog Number12000528
Company DUNS051624070
Company NameBIO-RAD LABORATORIES, 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 Usetrue
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

Customer Support Contacts

Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103610520530061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMNAssayed external control material for microbiology nucleic acid amplification (NAT) assays

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2016-09-19

On-Brand Devices [Amplichek]

00847661005995Amplichek II Level 3 MiniPak (A nucleic acid control.)
00847661005988Amplichek II Level 2 MiniPak (A nucleic acid control.)
00847661005971Amplichek II Level 1 MiniPak (A nucleic acid control.)
00847661005964Amplichek II Negative MiniPak (A nucleic acid control.)
00847661005957Amplichek II Level 3 (A nucleic acid control.)
00847661005940Amplichek II Level 2 (A nucleic acid control.)
00847661005933Amplichek II Level 1 (A nucleic acid control.)
00847661005926Amplichek II Negative (A nucleic acid control.)
03610520530092Amplichek I MiniPak (An assayed nucleic acid control.)
03610520530085Amplichek I Level 3 (An assayed nucleic acid control.)
03610520530078Amplichek I Level 2 (An assayed nucleic acid control.)
03610520530061Amplichek I Level 1 (An assayed nucleic acid control.)
03610520530054Amplichek I Negative (An assayed nucleic acid control.)

Trademark Results [Amplichek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMPLICHEK
AMPLICHEK
86619594 5110557 Live/Registered
Bio-Rad Laboratories, Inc.
2015-05-05

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