DEVICE: BIO-RAD (03610520014103)

Device Identifier (DI) Information

BIO-RAD
87530
In Commercial Distribution
87530
BIO-RAD
03610520014103
GS1

1
269902602 *Terms of Use
IPS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64818 Microplate/tube/assay card incubator IVD
An 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JRR REGULATOR, TEMPERATURE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 5 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 1 each
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Device Record Status

f47d4b2f-052c-42d6-ae2f-52be94f8e754
February 13, 2023
1
February 03, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)224-6723
TechSupport-Redmond@Bio-Rad.com
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