FDA.reportPublic FDA data

CHRONO-PAR

Primary DI
00811476010154
Brand
CHRONO-PAR
Company
CHRONO-LOG CORP
Model
390
Device description
Arachidonic Acid
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850592000PLATELET AGGREGATION REAGENTChrono-Log Corp.1985-05-13JBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811476010154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811476010154008114760101548114760101540811476010154

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00ALBUMIN 2-8C
Special Storage Condition, Specify00ARACHIDONIC ACID OILY DROP below -20C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-853-1130CHRONOLOG@CHRONOLOG.COM

Regulatory Flags#

DUNS number
002353696
Device count
1
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
00811476011007CHRONO-LOGAGGRO/LINK WBA Software2023-06-21
00811476011021CHRONO-LOGAGGRO/LINK8 Software2023-06-21
00811476011045CHRONO-LOGvW CoFactor Software2023-06-21
00811476011663CHRONO-LOGAGGRO/LINK Opti8 Software2023-06-21
00811476011670CHRONO-LOGvW CoFactor Opti8 Software2023-06-21
00811476010246Chrono-log490490-2D2016-10-11
00811476010253Chrono-log490490-X2016-10-11
00811476010369Chrono-log590590-2D2016-10-11
00811476010376Chrono-log590590-X2016-10-11
00811476010383Chrono-log5915912016-10-11
00811476010390Chrono-log591A591A2016-10-11
00811476010406Chrono-log5925922016-10-11
00811476010413Chrono-log592592-X2016-10-11
00811476010420Chrono-log592A592A2016-10-11
00811476010437Chrono-log592A592A-X2016-10-11
00811476010482Chrono-log700700-22016-10-11
00811476010499Chrono-log700700-X2016-10-11
00811476010956Chrono-log490490-4D2016-10-11
00811476010963Chrono-log590590-4D2016-10-11
00811476010987Chrono-log490 4+490 4+2016-12-28