Kallestad

Primary DI
00847865001595
Brand
Kallestad
Company
Bio-RAD Laboratories, Inc.
Model
30471
Catalog number
30471
Device description
Kallestad HEp-2 Cell Line Substrate
Published
2016-09-12
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
DBMANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810863000KALLESTAD HEP-2 CELL LINE SUBSTRATEKallestad Laboratories, Inc.1981-04-14DBM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865001595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865001595008478650015958478650015950847865001595

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Please see kit labeling for individual component temperature controls

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD-Redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

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08426950730101QUANTA Flash® M2 (MIT3) ReagentsINOVA DIAGNOSTICS, INC.DBM2018-01-26
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04049016027157Anti-M2-3E ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124887EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
04049016124894EUROLINE Profile Autoimmune Liver Disease 8 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGDBM2016-09-24
07333066014852EliA M2 WellPhadia ABDBM2016-09-23
07333066010908EliA M2 WellPhadia ABDBM2016-09-23
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00813545022310MA MS KDY Test(L) 96 TestSCIMEDX CORPORATIONDBM2016-09-19
00813545020279R. KDY Pack 8 WELLSCIMEDX CORPORATIONDBM2016-09-13
00813545020286M. KDY Pack 4 WELLSCIMEDX CORPORATIONDBM2016-09-13
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00847817016257KallestadBIO-RAD LABORATORIES, INC.DBM2016-09-12
00847865001205KallestadBio-RAD Laboratories, Inc.DBM2016-09-12