FDA.reportPublic FDA data

Kallestad

Primary DI
00847817000294
Brand
Kallestad
Company
BIO-RAD LABORATORIES, INC.
Model
96CP
Catalog number
96CP
Device description
Kallestad Anti-Cyclic Citrullinated Peptides (CCP) II Microplate EIA
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
NHXANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062045000EDIA ANTI-CCPEuro-Diagnostica AB2006-12-04NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817000294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817000294008478170002948478170002940847817000294

GMDN Terms#

Term, Definition table
TermDefinition
Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide antibody (CCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

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

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)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066015798EliA CCP WellPhadia ABNHX2026-01-29
07333066024202EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066024226EliA Dummy WellPhadia ABNHX2026-01-29
07333066015507EliA CCP WellPhadia ABNHX2026-01-29
07333066023908EliA IgG Calibrator WellPhadia ABNHX2026-01-29
07333066023939EliA Dummy WellPhadia ABNHX2026-01-29
07333066020907Phadia 5000EPhadia ABNHX2020-12-01
07333066020914Phadia 5000E+EPhadia ABNHX2020-12-01
07333066020921Phadia 2500EPhadia ABNHX2020-12-01
07333066020938Phadia 2500EEPhadia ABNHX2020-12-01
03610522053131BioPlex 2200BIO-RAD LABORATORIES, INC.NHX2019-11-27
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAAXIS-SHIELD DIAGNOSTICS LIMITEDNHX2019-08-02
07333066020020EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066014173EliA CCP Positive Control 2500/5000Phadia ABNHX2019-03-29
07333066020051EliA IgG CalibratorsPhadia ABNHX2019-03-26
07333066001036Dilution Plate, Phadia 250Phadia ABNHX2019-02-20
00380740151362AlinityAbbott GmbHNHX2018-12-04
00630414245669Atellica IM aCCPSiemens Healthcare Diagnostics Inc.NHX2018-10-19
04049016026853Anti-CCP ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNHX2016-09-24
00630414592312ADVIA Centaur® aCCP IgGSiemens Healthcare Diagnostics Inc.NHX2016-09-24
00630414601991IMMULITE® 2000 Systems CCP Anti-CCP IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDNHX2016-09-24
07333066012629EliA IgG ConjugatePhadia ABNHX2016-09-23
07333066012636EliA Sample DiluentPhadia ABNHX2016-09-23
07333066012704EliA IgG Curve ControlPhadia ABNHX2016-09-23
07333066012797EliA IgG Calibrator StripPhadia ABNHX2016-09-23
07333066012803EliA IgG Curve Control StripPhadia ABNHX2016-09-23
07333066012810EliA IgG Conjugate 50Phadia ABNHX2016-09-23
07333066012827EliA IgG Conjugate 200Phadia ABNHX2016-09-23
07333066012872EliA Sample DiluentPhadia ABNHX2016-09-23
07333066013015EliA CCP Positive Control 250Phadia ABNHX2016-09-23