FDA.report

GEM Check Coag Control-Normal for ACT

Primary DI
08426950452744
Brand
GEM Check Coag Control-Normal for ACT
Company
INSTRUMENTATION LABORATORY COMPANY
Model
06260060500
Catalog number
06260060500
Device description
GEM Check Coag Control-Normal for ACT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GGNPLASMA, COAGULATION CONTROL

Product Code Classifications

CodeDeviceSpecialtyClass
GGNPlasma, Coagulation ControlHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950452744PrimaryGS10
18426950452741Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950452744084269504527448426950452744
1842695045274118426950452741

GMDN Terms

TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of 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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags

DUNS number
557223252
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00195226000535ACL TOP 770 LAS00000280037000002800372024-05-15
00195226000542ACL TOP 770s00000280017000002800172024-05-15
00195226000559ACL TOP 57000000280047000002800472024-05-15
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00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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