FDA.report

Liquichek

Primary DI
00847661003410
Brand
Liquichek
Company
BIO-RAD LABORATORIES, INC.
Model
548X
Catalog number
548X
Device description
Liquichek Tumor Marker Control Trilevel MiniPak (A human based assayed tumor marker control.)
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847661003410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661003410008476610034108476610034100847661003410

GMDN Terms

TermDefinition
Multiple tissue-associated protein/tumour marker IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple proteins or tumour markers associated with specific tissues in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-70 Degrees Celsius-20 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)854-6737qsd.techservice@bio-rad.com

Regulatory Flags

DUNS number
051624070
Device count
1
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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03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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