AccessGUDID - DEVICE: A1CNow+ Controls™ Levels 1+2 (00381930737014)

GUDID

Device Identifier (DI) Information

Brand Name: A1CNow+ Controls™ Levels 1+2
Version or Model: 737
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 737
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381930737014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44435	Glycated haemoglobin (HbA1c) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (specified) analyte controls (assayed and unassayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103744	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: When stored frozen at -30°C to -10°C, the control remains stable until the expiration date printed on the label.
Special Storage Condition, Specify: 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, Specify: The control may be received thawed and should be re-frozen upon arrival.
Special Storage Condition, Specify: 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 Temperature: between -30 and -10 Degrees Celsius
Storage Environment Temperature: between -22 and 14 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc66061f-8e74-4fee-80d4-453345fe1193
Public Version Date: January 23, 2023
Public Version Number: 3
DI Record Publish Date: November 15, 2019