Autokit Micro Albumin 999-06001

GUDID 04987481164666

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Albumin IVD, kit, nephelometry/turbidimetry
Primary Device ID04987481164666
NIH Device Record Key78fa0a28-3246-4b80-a9eb-1f65f2cdc54a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutokit Micro Albumin
Version Model Number999-06001
Catalog Number999-06001
Company DUNS690598875
Company NameFUJIFILM WAKO PURE CHEMICAL 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com
Phone781-323-5300
Emailfmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987481164666 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-09
Device Publish Date2021-07-30

Devices Manufactured by FUJIFILM WAKO PURE CHEMICAL CORPORATION

04987481164666 - Autokit Micro Albumin2021-08-09In-Vitro Diagnostic Use
04987481164666 - Autokit Micro Albumin2021-08-09 In-Vitro Diagnostic Use
04987481164642 - NEFA Linearity Material2021-06-09 In-Vitro Diagnostic Use
04987481164659 - Complement Control2021-06-09 In-Vitro Diagnostic Use
04987481164673 - Autokit Micro Albumin Control Set2021-06-09 In-Vitro Diagnostic Use
04987481164536 - L-Type LDL-C Reagent 12021-06-09 In-Vitro Diagnostic Use
04987481164543 - L-Type LDL-C Reagent 22021-06-09 In-Vitro Diagnostic Use
04987481164604 - HR Series NEFA-HR(2) Color Reagent A2021-06-09 In-Vitro Diagnostic Use
04987481164611 - HR Series NEFA-HR(2) Solvent A2021-06-09 In-Vitro Diagnostic Use

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