FDA.reportPublic FDA data

Dade® PFA Collagen/ADP Test Cartridge

Primary DI
00842768003684
Brand
Dade® PFA Collagen/ADP Test Cartridge
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10445699
Catalog number
B4170-21A
Device description
To aid in the detection of platelet dysfunction in citrated human whole blood
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOZSYSTEM, AUTOMATED PLATELET AGGREGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOZSystem, Automated Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060489000DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTSDade Behring, Inc.2006-07-21JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768003684PrimaryGS10
00842768019784Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768003684008427680036848427680036840842768003684
00842768019784008427680197848427680197840842768019784

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents and a nephelometry/turbidimetry method. Platelet aggregation agents used may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233XX@XX.XX
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

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Primary DI, Brand, Company table
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14589448510089PL ChipZACROS CORPORATIONJOZ2024-12-12
14589448510096PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
14589448510102BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510013T-TAS 01 Total Thrombus Formation Analysis SystemZACROS CORPORATIONJOZ2024-12-06
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00811476011045CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
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G0561009700AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012410AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012971Arachidonic AcidBio/Data CorporationJOZ2022-03-23
G0561013101PAR/PAK IIBio/Data CorporationJOZ2022-03-23
G0561013111EpinephrineBio/Data CorporationJOZ2022-03-23
G0561013121ADPBio/Data CorporationJOZ2022-03-23
G0561015621CollagenBio/Data CorporationJOZ2022-03-23
G0561015801BETA/PakBio/Data CorporationJOZ2022-03-23
10711234500095VerifyNow SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.JOZ2021-04-06
00856893004027AggreguideAGGREDYNE, INC.JOZ2019-09-23
00856893004010AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
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20856893004014AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
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10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-08-18
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