AIA-PACK bHCG Calibration Verification Test Set

GUDID 14560189212296

TOSOH CORPORATION

Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control Human chorionic gonadotropin beta-subunit IVD, control
Primary Device ID14560189212296
NIH Device Record Key9afdc523-7dc9-48fd-bb0a-1b1feb8b2a6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIA-PACK bHCG Calibration Verification Test Set
Version Model NumberN/A
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com
Phone650-615-8134
EmailDave.Wurtz@tosoh.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104560189212299 [Primary]
GS114560189212296 [Package]
Contains: 04560189212299
Package: [6 Units]
In Commercial Distribution

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-04-01
Device Publish Date2019-07-25

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