POINTE SCIENTIFIC ALBUMIN 12-A7502-160

GUDID 00811727013385

For the quantitative determination of Albumin in serum.

POINTE SCIENTIFIC, INC.

Albumin IVD, kit, spectrophotometry
Primary Device ID00811727013385
NIH Device Record Keyba1c63ee-0a05-40de-8773-fe9dfd6fc696
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOINTE SCIENTIFIC ALBUMIN
Version Model Number12-A7502-160
Catalog Number12-A7502-160
Company DUNS045623154
Company NamePOINTE SCIENTIFIC, INC.
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

Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com
Phone800-445-9853
Emailtechservice@medtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727013385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CIXBromcresol Green Dye-Binding, Albumin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [POINTE SCIENTIFIC ALBUMIN]

00811727013385For the quantitative determination of Albumin in serum.
00811727010032For the quantitative determination of Albumin in serum.
00811727010025For the quantitative determination of Albumin in serum.
00811727010018For the quantitative determination of Albumin in serum.

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