Sheep anti-human Factor XIII Analyte Specific Reagent

GUDID 10629009145016

The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application.

Affinity Biologicals Inc

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD
Primary Device ID10629009145016
NIH Device Record Key1e9e17e5-2e2c-4f9f-a815-632b80729af3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSheep anti-human Factor XIII Analyte Specific Reagent
Version Model NumberSAFXIII-IG-ASR-500
Company DUNS249373515
Company NameAffinity Biologicals Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110629009145016 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

On-Brand Devices [Sheep anti-human Factor XIII Analyte Specific Reagent]

10629009145016The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's applicat
10629009140516The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's applicat

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.