FDA.reportPublic FDA data

A1CNow®+ Multi-Use Test System (10 count)

Primary DI
00381933024012
Brand
A1CNow®+ Multi-Use Test System (10 count)
Company
POLYMER TECHNOLOGY SYSTEMS, INC.
Model
3024
Catalog number
3024
Device description
The A1CNow®+ Multi-Use Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090413000A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECBayer Healthcare, LLC2009-05-14LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00381933024012PrimaryGS10
10381933024019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00381933024012003819330240123819330240120381933024012
1038193302401910381933024019

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00If refrigerated, ensure components are at room temperature prior to use.
Special Storage Condition, Specify00If the temperature label placed on the outside of every kit is exposed to a temperature in excess of 122 degrees F / 50 C, the dot on the label will turn red and the product should not be used.
Special Storage Condition, Specify00Product may be stored for a total of four months at room temperature (18-25 degrees C) anytime before the expiration date.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)870-5610customerservice@ptsdiagnostics.com
+1(888)877-5610customerservice@ptsdiagnostics.com

Regulatory Flags#

DUNS number
835772872
Device count
10
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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