FDA.reportPublic FDA data

Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL

Primary DI
00896863002066
Brand
Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL
Company
QUANTIMETRIX CORPORATION
Model
1510-02
Catalog number
1510-02
Device description
The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896863002066PrimaryGS10
M0511510021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896863002066008968630020668968630020660896863002066

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, controlA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature-30 Degrees Celsius-10 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(310) 536-0006sales@quantimetrix.com

Regulatory Flags#

DUNS number
010717890
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00896863002424Chromascopics Control Level 1&2 Set 2x25mL (International)1540-031540-032023-05-04
00896863002356QuanTtest Human Protein Standards Set3410-023410-022021-09-10
00896863002004Dropper Spinal Fluid Control Level 1 Set 3x3mL1451-311451-312018-09-26
00896863002011Dropper Spinal Fluid Control Level 2 Set 3x3mL1452-311452-312018-09-26
00896863002073Dropper Spinal Fluid Control Level 1&2 Set 2x3mL1450-011450-012018-09-26
00896863002042Chromascopics Control Level 1&2 Set 4x120mL (Domestic)1540-021540-022018-09-26
00896863002349QuanTtest Red Pyrogallol Red Reagent5210-125210-122019-09-27
00896863002394Dip&Spin Urinalysis Dipstick and Microscopics Control Level 1&2 Set 2x25mL1470-021470-022019-03-13
00896863002028Sweat Control Level 1, 2, & 3 Set 9x3mL1190-011190-012018-09-26
00896863002035Chromascopics Control Level 1&2 Set 4x120mL (International)1540-011540-012018-09-26
00896863002059Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL1290-011290-012018-09-26
00896863002080Spinalscopics Control Level 1 Set 3x3mL1461-311461-312018-09-26
00896863002097Spinalscopics Control Level 2 Set 3x3mL1462-311462-312018-09-26
00896863002103Microbumin Microalbumin Control Level 1&2 Set 10x7mL1250-011250-012018-09-26
00896863002110Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL1440-021440-022018-09-26
00896863002127Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL1440-031440-032018-09-26
00896863002134Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL1440-011440-012018-09-26
00896863002141Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL1442-611442-612018-09-26
00896863002158Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL1440-041440-042018-09-26
00896863002165Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL1440-061440-062018-09-26

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