FDA.reportPublic FDA data

BIO-RAD

Primary DI
03610520014103
Brand
BIO-RAD
Company
BIO-RAD
Model
87530
Catalog number
87530
Device description
IPS
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRRREGULATOR, TEMPERATURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRRRegulator, TemperatureClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610520014103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610520014103036105200141033610520014103

GMDN Terms#

Term, Definition table
TermDefinition
Microplate/tube/assay card incubator IVDAn electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport-Redmond@Bio-Rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520013571PR 410091587915872023-02-03
03610522189380Platelia12014064120140642023-01-08
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002919Select63727637272022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12
03610520013854Geenius723392015-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815236021104StaFreezLCR HALLCREST, LLC.JRR2022-06-20
10815236021135LabTemp 40LCR HALLCREST, LLC.JRR2022-06-20
20815236021101StaFreezLCR HALLCREST, LLC.JRR2022-06-20
20815236021132LabTemp 40LCR HALLCREST, LLC.JRR2022-06-20
10815236021128LabTemp 20LCR HALLCREST, LLC.JRR2022-06-16
20815236021125LabTemp 20LCR HALLCREST, LLC.JRR2022-06-16
M74450001StaFreezBIOSYNERGY, INC.JRR2017-06-01
M74460001LabTemp 20BIOSYNERGY, INC.JRR2017-06-01
M74450002StaFreezBIOSYNERGY, INC.JRR2017-06-01
M74460002LabTemp 20BIOSYNERGY, INC.JRR2017-06-01
M74461001LabTemp 40BIOSYNERGY, INC.JRR2017-06-01
00816744029067NICO MyriadNICO CORPORATIONJRR2016-09-14