A1CNow+ Controls™ Levels 1+2 737

GUDID 00381930737014

The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the A1CNow system. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.

POLYMER TECHNOLOGY SYSTEMS, INC.

Glycated haemoglobin (HbA1c) IVD, control
Primary Device ID00381930737014
NIH Device Record Keybc66061f-8e74-4fee-80d4-453345fe1193
Commercial Distribution StatusIn Commercial Distribution
Brand NameA1CNow+ Controls™ Levels 1+2
Version Model Number737
Catalog Number737
Company DUNS835772872
Company NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Device Count1
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

Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)870-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com
Phone+1(888)877-5610
Emailcustomerservice@ptsdiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, SpecifyBetween 0 and 0 *Once the control is thawed and opened, it may be stored refrigerated at 2-8°C (36 to 46°F) for 6 months or at room temperature at 18°C to 25°C (64 to 77°F) for 21 days.
Special Storage Condition, SpecifyBetween 0 and 0 *The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, SpecifyBetween 0 and 0 *Discard the control if there is any evidence of microbial contamination. Discard controls in the same manner as other biological specimens according to local guidelines.
Storage Environment TemperatureBetween -30 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 14 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100381930737014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

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