UniQ® PINP RIA

Primary DI: 06438115000082
Brand: UniQ® PINP RIA
Company: Aidian Oy
Model: 67034
Catalog number: 67034
Device description: UniQ® PINP RIA is a quantitative radioimmunoassay designed for the measurement of the concentrationof intact aminoterminal propeptide of type I procollagen, an indicator of osteoblastic activity, in human serum.
Published: 2016-04-13
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#

Code, Name table
Code	Name
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Code, Device, Specialty table
Code	Device	Specialty	Class
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	2

Submission, Supplement table
Submission	Supplement
K043125	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K043125	000	ORION DIAGNOSTICA UNIQ PINP RIA	Orion Diagnostica, OY	2005-05-04	CIN

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
06438115000082	Primary	GS1	0

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
06438115000082	06438115000082	6438115000082

Term, Definition table
Term	Definition
Procollagen type I N-terminal propeptide (PINP) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of procollagen type I N-terminal propeptide (PINP) in a clinical specimen, using a radioimmunoassay method. PINP is an indicator of osteoblastic activity and used in the management of postmenopausal osteoporosis.

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Method table
Method

Phone, Email table
Phone	Email
+358104261	product.support@oriondiagnosti
+358103093000	product.support@aidian.eu

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
06438115000099	QuikRead go® CRP	145215	145215	2016-06-01
06438115000105	QuikRead go® CRP Verification set	145216	145216	2016-06-01
06438115000112	QuikRead go® CRP Control set	145217	145217	2016-06-01
06438115000198	QuikRead go® Instrument	145218	145218	2016-06-01
06438115000006	Uricult® CLED+Polymyxin / MacConkey	68017	1003	2016-05-13
06438115000013	Uricult® CLED+Polymyxin /EMB	68018	1002	2016-05-13
06438115000020	Uricult® CLED/MacConkey	68019	1001	2016-05-13
06438115000037	Uricult CLED/EMB	68014	1000	2016-05-13
06438115000044	Uricult® Trio	68197	68197	2016-05-12

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M52530580	TITAN GEL Alkaline Phosphatase Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M52533480	SPIFE ALP Separation Enhancer	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M52551020	Alkaline Phosphatase Indolyl Blue Reagent Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M5255510310	TITAN GEL Alkaline Phosphatase Reagent Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M5255520550	SPIFE Alkaline Phosphatase Reagent Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M5255523950	SPIFE Alkaline Phosphatase-20,40 Gel Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
M5255526040	SPIFE Alkaline Phosphatase Gel Kit	HELENA LABORATORIES CORPORATION	CIN	2016-09-07
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