Coatest APCR Control Plasma Level 1 82 2650 63

GUDID 08426950088912

Coatest APCR Control Plasma Level 1

INSTRUMENTATION LABORATORY COMPANY

Multiple coagulation factor IVD, control
Primary Device ID08426950088912
NIH Device Record Key17a3b13e-1d9a-4b88-b345-33c3d8a49fd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoatest APCR Control Plasma Level 1
Version Model Number82 2650 63
Catalog Number82 2650 63
Company DUNS557223252
Company NameINSTRUMENTATION LABORATORY COMPANY
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 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

Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com
Phone1-800-678-0710
Emailtechsupport.na@werfen.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Stability after reconstitution is 6 hours at 2-25°C or 3 months at -20°C or below. The frozen reagent should be thawed at 37°C and gently mixed before use. Do not refreeze.

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950088912 [Primary]
GS118426950088919 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGWTEST, TIME, PARTIAL THROMBOPLASTIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-07-08
Device Publish Date2016-09-23

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