ST AIA-PACK BNP 0025228

GUDID 04560189212879

TOSOH CORPORATION

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04560189212879
NIH Device Record Keyaa8f678b-2844-4646-bc92-dc4c7708ce72
Commercial Distribution StatusIn Commercial Distribution
Brand NameST AIA-PACK BNP
Version Model NumberN/A
Catalog Number0025228
Company DUNS690571724
Company NameTOSOH CORPORATION
Device Count5
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

Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
Emaildave.wurtz@tosoh.com
Phone650-636-8228
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
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
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
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
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
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
GS104560189212879 [Unit of Use]
GS114560189212876 [Primary]

FDA Product Code

NBCTest, Natriuretic Peptide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-11
Device Publish Date2021-01-01

Devices Manufactured by TOSOH CORPORATION

24560189216321 - CL AIA-PACK Prolactin II TEST CUP2025-09-09
24560189216338 - CL AIA-PACK Prolactin II ADJUSTER SET2025-09-09
24560189216628 - CL AIA-PACK hs-E2 TEST CUP2025-09-09
24560189216635 - CL AIA-PACK hs-E2 ADJUSTER SET2025-09-09
24562185395390 - CL AIA-PACK SAMPLE DILUTING REAGENT A2025-09-09
24562185395444 - CL AIA-PACK T3 TEST CUP2025-09-09
24562185395451 - CL AIA-PACK T3 ADJUSTER SET2025-09-09
24562185399657 - CL AIA-PACK SAMPLE DILUTING REAGENT D2025-09-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.