FDA.reportPublic FDA data

Vysis

Primary DI
00884999027060
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
07J21-012
Catalog number
07J21-012
Device description
ProbeChek Low Level Male 95% XX/5% XY
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIRCELLS, ANIMAL AND HUMAN, CULTURED
OXPDna-probe kit, human chromosome x and y, bmt engraftment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIRCells, Animal And Human, CulturedHematology1
OXPDna-Probe Kit, Human Chromosome X And Y, Bmt EngraftmentImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954214000CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITVysis1997-01-21OXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999027060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999027060008849990270608849990270600884999027060

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The ProbeChek Control Slides shold be stored in a sealed container with desiccant to protect from humidity
Storage Environment Temperature-20 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
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
00884999051928Alinity m09N15-03C09N15-03C2026-07-27
00884999051737RealTime09R20-00109R20-0012026-07-06
00884999051744Alinity m09R20-00209R20-0022026-07-06
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700575016899PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2026-04-29
04015630972524HER2 Dual ISH 3-in-1 Xenograft SlidesVentana Medical Systems, Inc.KIR2021-02-03
04015630971091HER2 3-in-1 Xenograft Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
04015630971909HPV FAMILY 6 SYSTEM CONTROL SLIDES [B]Ventana Medical Systems, Inc.KIR2021-01-29
04015630971961HPV 3 in 1 System Control SlidesVentana Medical Systems, Inc.KIR2021-01-29
05700573001736PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
05700571112755PD-L1 Control SlidesAGILENT TECHNOLOGIES, INC.KIR2020-11-17
30014613339571Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-10-02
30014613339564Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-09-25
30014613339274Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
30014613339281Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2020-07-14
B7829500A07TdT Control Cell SuspensionSupertechs, Inc.KIR2019-10-08
30014613331377Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331384Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331391Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331407Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331414Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331421Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331438Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331445Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331698Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331704Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331711Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331728Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331735Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331742Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331759Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331766Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331773Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21
30014613331780Fresh CellsDIAGNOSTIC HYBRIDS, INC.KIR2018-09-21