FDA.reportPublic FDA data

Cfas HbA1c

Primary DI
04015630921096
Brand
Cfas HbA1c
Company
Roche Diagnostics GmbH
Model
4528417190
Catalog number
4528417190
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRZCALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRZCalibrator For Hemoglobin And Hematocrit MeasurementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052101000C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche Diagnostics2005-08-26KRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630921096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630921096040156309210964015630921096

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414287201Atellica HEMA CalibratorSiemens Healthcare Diagnostics Inc.KRZ2026-02-06
00380740151294AlinityAbbott GmbHKRZ2023-11-16
00630414224343ADVIA® 120/2120/2120i SETpointSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
00630414600826ADVIA® 360/560 CalibratorSiemens Healthcare Diagnostics Inc.KRZ2016-09-24
20844509000246Cal-ChexSTRECK, INC.KRZ2016-09-16
20844509000314Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
30844509000243Cal-Chex STRECK, INC.KRZ2016-09-16
30844509000311Cal-Chex A Plus STRECK, INC.KRZ2016-09-16
40844509000318Cal-Chex A PlusSTRECK, INC.KRZ2016-09-16
00847817000324VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817011979VARIANT II Hemoglobin A1cBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817013966VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014154VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014406VARIANT II TURBOBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00847817014871VARIANT II TURBO LinkBIO-RAD LABORATORIES, INC.KRZ2016-09-12
00380740003609ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003616ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00380740003623ARCHITECTABBOTT LABORATORIESKRZ2016-09-09
00812137010223Boule CalCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-06
00812137010360CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00812137010421CDS Hematology CalibratorCLINICAL DIAGNOSTIC SOLUTIONS, INC.KRZ2016-09-02
00380740017071CELL-DYNABBOTT LABORATORIESKRZ2016-06-06
00380740020347CELL-DYNABBOTT LABORATORIESKRZ2016-06-06