FDA.reportPublic FDA data

FREND AP

Primary DI
08809317540467
Brand
FREND AP
Company
NanoEnTek, Inc.
Model
F10AP
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540467088093175404678809317540467

GMDN Terms#

Term, Definition table
TermDefinition
Heating block IVDAn electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source typically in the laboratory to heat liquids and in vitro diagnostic specimens/laboratory materials.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687910463
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809317540252ADAM-rWBCADAM-rWBC ADAM-rWBC2018-06-11
08809317540269ADAM-rWBC KitAD1K-050AD1K-0502016-09-30
08809317540276ADAM-rWBC SystemADAM-rWBC SystemADAM-rWBC System2016-09-30
08809317540498ADAM-rWBC2ADAM-rWBC2ADAM-rWBC22018-06-19
08809317540504ADAM-rWBC2 SystemADAM-rWBC2 SystemADAM-rWBC2 System2018-06-19
08809317540207FREND SystemF102018-05-04
08809317540153FREND TestosteroneFRTE-HBFRTE 0202016-11-28
08809317540375FREND TestosteroneFRTE-APFRTEAP 0202018-05-04
08809317541143r-Control RBC and PLTADRCADRC 0202021-12-08
08809317540993ADAM-rWBC HTADAM-rWBC HTADAM-rWBC HT2021-02-15
08809317541006ADAM-rWBC KitADHK-050ADHK-0502021-02-15
08809317540528FREND Free T4 Linearity KitFLK-FT42018-10-01
08809317540559FREND TSH Linearity KitFLK-TSH2018-10-01
08809317540566FREND Vitamin D Linearity KitFLK-VTD2018-10-01
08809317540627ADAMIIADAMII2020-09-02
08809317540634ADAMII-CD34 KitCD34K-050CD34K-0502020-09-02
08809317540917COVID-19 total Ab Control LQFIC-COALQFIC-COALQ2020-09-02
08809317540924FREND COVID-19 total AbFREND COVID-19 total AbFRCOA 0202020-09-02
08809317540825FREND Blocking ReagentFRBR 015FRBR 0152020-03-24
08809317540016FREND TSHFRTS 025FRTS 0252016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973843220949ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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06973843220987ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
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06973843221038ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221052ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221069ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221076ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221083ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221120Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221137Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221144ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06936895301318BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301325BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301332BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301349BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
09349458005443ThermoBrite Elite InstrumentLEICA BIOSYSTEMS MELBOURNE PTY LTDJRG2022-07-18
00815236020926HemoTemp II ActivatorLCR HALLCREST, LLC.JRG2022-06-16