FDA.reportPublic FDA data

STA® - Unicalibrator

Primary DI
13607450006756
Brand
STA® - Unicalibrator
Company
DIAGNOSTICA STAGO
Model
00675
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GIZPLASMA, CONTROL, NORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922021000UNICALIBRATOR KITAmerican Bioproducts Co.1992-06-09GIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13607450006756PrimaryGS10
03607450006759Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1360745000675613607450006756
03607450006759036074500067593607450006759

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor 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 determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
6
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
13607450006749STA® - Fibrinogen 5006742016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09
03607450871111STA Coag Expert®V7871112022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006821Berichrom® Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.GIZ2016-09-20
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDGIZ2016-09-12
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)HELENA LABORATORIES CORPORATIONGIZ2016-09-07
00855360006243REAADS Coagulation Control 1CORGENIX MEDICAL CORPORATIONGIZ2016-07-14