Pointe CRP Reagent 16-C7568-480

GUDID 00811727016126

Pointe CRP Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 60ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.

POINTE SCIENTIFIC, INC.

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
Primary Device ID00811727016126
NIH Device Record Key5114e648-bc19-46eb-a577-3f93c668366b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePointe CRP Reagent
Version Model Number16-C7568-480
Catalog Number16-C7568-480
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100811727016126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCKC-Reactive Protein, Antigen, Antiserum, And Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-08
Device Publish Date2021-01-30

On-Brand Devices [Pointe CRP Reagent]

00811727016126Pointe CRP Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 60ml R2. For the q
00811727015815Pointe CRP Reagent 4 x 60ml R1, 4 x 60ml R2. For the quantitative determination of C-reactive
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