FDA.reportPublic FDA data

Vysis

Primary DI
00884999026216
Brand
Vysis
Company
ABBOTT MOLECULAR INC.
Model
07J03-005
Catalog number
07J03-005
Device description
SpectrumGreen Male Total Human Genomic DNA, 25 uL (300 ng/uL)
Published
2017-12-15
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
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999026216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999026216008849990262168849990262160884999026216

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid hybridization detection IVD, controlA material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLELonza VerviersPPM2026-03-30
05407010129861T-32 1000L bagLonza VerviersPPM2026-03-26
05407010129878T-32 200L bagLonza VerviersPPM2026-03-26
05407010129885NaAc-35 - 1000L bagLonza VerviersPPM2026-03-26
05407010129892NaAc-35 - 200L BagLonza VerviersPPM2026-03-26
05407010129908NaAc-35 -1L Sample bagLonza VerviersPPM2026-03-26
05407010129915NaP-55 - 1000LLonza VerviersPPM2026-03-26
05407010129922NaP-55 - 1L sample bagLonza VerviersPPM2026-03-26
05407010129939NaAc-36 -1000L BagLonza VerviersPPM2026-03-26
05407010129946NaAc-36 -1L Sample BagLonza VerviersPPM2026-03-26
05407010129953NaAc-36 -500L BagLonza VerviersPPM2026-03-26
00630414289984Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414290034Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
04049016152019EUROSORB (IFA)EUROIMMUN Medizinische Labordiagnostika AGPPM2025-11-21
05407010129243KH-020 BF-1 1L Sample BagLonza VerviersPPM2025-10-30
05407010129250KH-020 BF-1 1000L BagLonza VerviersPPM2025-10-30
05407010129267KH-020 BF-1 500L BagLonza VerviersPPM2025-10-30
05407010129274NTT-001-L Buffer - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129311NTT-001-K : 1M NaCl - 200L bagLonza VerviersPPM2025-10-30
05407010129328NTT-001-K : 1M NaCl - 500L bagLonza VerviersPPM2025-10-30
05407010129335NTT-001-R : 150 mM NaCl - 1000L bagLonza VerviersPPM2025-10-30
05407010129342NTT-001-R : 150 mM NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30