FDA.reportPublic FDA data

Amplichek

Primary DI
00847661005957
Brand
Amplichek
Company
BIO-RAD LABORATORIES, INC.
Model
12000204
Catalog number
12000204
Device description
Amplichek II Level 3 (A nucleic acid control.)
Published
2016-09-19
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
PMNAssayed external control material for microbiology nucleic acid amplification (NAT) assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150058000Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories2016-03-28PMN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661005957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661005957008476610059578476610059570847661005957

GMDN Terms#

Term, Definition table
TermDefinition
MRSA nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
051624070
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522040148QXDx12008020120080202026-08-19
03610522040131QXDx12008019120080192026-08-14
03610522991303QX60012024779120247792026-08-14
03610523006433QXDx12024810120248102026-08-14
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12

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