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 Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 08426950088912
• NIH Device Record Key: 17a3b13e-1d9a-4b88-b345-33c3d8a49fd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coatest APCR Control Plasma Level 1
• Version Model Number: 82 2650 63
• Catalog Number: 82 2650 63
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 1-800-678-0710
• Email: techsupport.na@werfen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Agency	Device ID
GS1	08426950088912 [Primary]
GS1	18426950088919 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945940

FDA Product Code

• GGW: TEST, TIME, PARTIAL THROMBOPLASTIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-09-23

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